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Informs that based on info & test data submitted in 970227 application,Model Gammacell 40 irradiator found acceptable for licensing purposes in accordance with conditions of registration certificate NR-220-D-101-S.

Accession Number: ML20138M295

Date Released: Monday, October 28, 2024

Package Contents

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• ML20198F054 - Informs that based on info & test data submitted in 970227 application,Model Gammacell 40 irradiator found acceptable for licensing purposes in accordance with conditions of registration certificate NR-220-D-101-S. (1 page(s), 12/21/1998)
• ML20198F188 - Forwards marked-up draft GC-40 Device registration certificate.Changes fairly minor & made in spirit of making registration more general where safety not issue. (15 page(s), 5/26/1998)
• ML20198F211 - Forwards draft of Gammacell 40 certificate as requested in 980403 ltr.Requests that draft be screened for technical correctness & that marked up copy with corrections be faxed back to J Jankovich. (14 page(s), 4/9/1998)
• ML20198H419 - Discusses request for withholding info from public disclosure,design changes to MDS Nordion Inc C-188 Sealed Source & Gammacell-40 device,respectively.Determined info to be proprietary & will be withheld from public disclosure. (2 page(s), 4/15/1998)
• ML20198F257 - Provides supplement to 980227 application for amend to Gammacell 40 registration,per telcon.IN/OM 1223 GC40E+ (Rev 3),IN/OM 1224 GC40E+ (Rev 3) & IN/OM 1225GC40E+ (Rev 3) encl.Draft of registration certificate requested. (1 page(s), 4/3/1998)
• ML20198F355 - Informs that MDS Nordion will proceed with plans to ship Gammacell 40 (SSD Registry NR-220-D-101-S) on 980420 in accordance with 980222 ltr & 980325 conversation,unless otherwise advised. (7 page(s), 4/3/1998)
• ML20198F440 - Requests that encl documentation re IN/DS 1389 GC-40(1) & Affidavit respecting portions of document,be accepted as request for rev of sealed source & device registration NR-220-D-101-S.Gammacell 40 shipment will be on 980420. (1 page(s), 2/27/1998)
• ML20198F484 - Affidavit of G Malkoske.Affidavit re proprietary info in MDS Nordion technical rept IN/DS 1389 GC-40(1) & request that info be withheld from disclosure. (2 page(s), 2/26/1998)
• ML20198F615 - "GC40 Design Change Evaluation." (16 page(s), 2/19/1998)