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Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Remote Afterloader Source Assembly for models 721-724.Cerificate:NR-555-S-104-S.(Amended in Entirety).

Accession Number: ML20112D892

Date Released: Sunday, October 27, 2024

Package Contents

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• ML20112D934 - Provides revised page three to application to reflect quality control procedures for Models 721-724 source assemblies to include tensile test of each source assembly. (4 page(s), 1/29/1993)
• ML20112D945 - Confirms application for registration w/FDA as contract manufacturer & informs that Mick Radionuclear Instruments Inc,distributor of sources,applied to FDA under 501K for sources per telcon on 900227. (2 page(s), 2/27/1990)
• ML20112D952 - Forwards test repts requested per telcon on 891121 re application for Health & Safety Review & Registration of Models 721-723 Source Assemblies. (2 page(s), 11/22/1989)
• ML20112D954 - Test rept of models 721,722 & 723 source assembly tensile. (1 page(s), 11/22/1989)
• ML20112D963 - Testrept of models 721,722 & 723 source assembly tensile. (1 page(s), 11/15/1989)
• ML20112D967 - Provides expected radiation intensities from Models 721-723 Source Assemblies per telcon on 891117. (1 page(s), 11/17/1989)
• ML20112D970 - Forwards copies of drawings 72101,77201,77202,77301 & 302 as requested per telcon on 891115. (6 page(s), 11/15/1989)
• ML20112D974 - Forwards check inadvertently omitted from 890607 application requesting Health & Safety Review & Registration of Models 721-723. (1 page(s), 6/9/1989)
• ML20112D980 - Forwards application for Health & Safety Review & Registration of Models 721-723 Source Assemblies for medical brachytherapy & check to cover fee for review.W/o encls. (1 page(s), 6/7/1989)
• ML20112D983 - Responds to comments raised in telcon of 920213 by revising application of 911004. (6 page(s), 9/18/1992)
• ML20112E003 - Submits info re application for expedited amend to models 702 & 721-724 Source Assemblies & encloses drawing 79901 & check to cover fees.W/o encls. (4 page(s), 5/1/1996)
• ML20112E015 - Forwards corrected page two to registration certificate NR-555-S-104-S issued 930201.W/o encl. (1 page(s), 3/15/1993)
• ML20112E026 - Concludes that Model 724 source assembly acceptable for licensing purposes IAW conditions of encl registration certificate & advises that manufacture & distribution of product IAW application & registration certificate.W/o encl. (1 page(s), 2/1/1993)
• ML20112E034 - Informs that sufficient info to perform thorough review of application for amend dtd 911004 & telcon on 920211 requesting additional info not received to date.Review will be considered abandoned within 30 days. (1 page(s), 6/18/1992)
• ML20112E071 - Responds to questions re application for amend to registration for Models 721-724 Remote Afterloader Source Assemblies to include Model 774 Source Capsule per telcon on 950830. (43 page(s), 11/3/1995)