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SSD Case 01-23 - DRAXIMAGE, BrachySeed TM Pd-103 Model Pd-1 Source Application, NR-1121-S-102-S.

Accession Number: ML013170492

Date Released: Monday, July 2, 2001

Package Contents

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• ML011990590 - Draximage - Submission of 510(k) approval letter issued by the Food & Drug Administration for their Brachyseed PD-103 application. (3 page(s), 7/17/2001)
• ML013030296 - DRAXIMAGE - reviewer checklist for BrachySeedTM Pd-103 Model Pd-1 source, NR-1121-S-102-S. (5 page(s), 10/30/2001)
• ML013030545 - DRAXIMAGE - cover letter issuing SSD certificate of registration number NR-1121-S-102-S for the BrachySeedTM Pd-103 Model Pd-1 Source. (2 page(s), 11/9/2001)
• ML013170490 - DRAXIMAGE - cover letter issuing SSD certificate of registration number NR-1121-S-102-S for the BrachySeedTM Pd-103 Model Pd-1 Source, signed version. (2 page(s), 11/9/2001)
• ML020360494 - DRAXIMAGE - RAI 1A for the Pd-1 source application (5 page(s), 10/24/2001)
• ML020360498 - DRAXIMAGE - Request for Additional Information Re Pd-1 source application. (3 page(s), 10/25/2001)
• ML020390040 - DRAXIMAGE - Pd-1 Source, Response to RAI 1A, Color Pics Submitted. (5 page(s), 10/25/2001)
• ML021400250 - DRAXIMAGE Inc, Response to RAI 1A, first 8 pages, all text. (8 page(s), 10/25/2001)