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Mills Biopharmaceutical Therapeutic Seed Source Models I-125SL and I-125SH are acceptable for licensing purposes in accordance with regidtration certificate (NR-1081-S-101-S).

Accession Number: ML993400467

Date Released: Friday, December 3, 1999

Package Contents

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• ML993400024 - Mills Biopharmaceutical Therapeutic Seed Source Models I-125SL and I-125SH are acceptable for licensing purposes in accordance with registration certificate (NR-1081-S-101-S). (1 page(s), 11/30/1999)
• ML993400050 - Mills Biopharamaceutical Therapeutic Seed Source Models I-125SL and I-125SH are acceptable for licensing purposes in accordance with registration certificate (NR-1081-S-101-S). (13 page(s), 12/1/1999)
• ML993400051 - Forwards enclosed raw material specification sheets for argon silver spheres.sodium iodine-125 and titanium tuabing. (7 page(s), 8/2/1999)
• ML993400132 - Forwards application for sealed source and device evaluation and registration. (2 page(s), 4/1/1999)
• ML993400065 - Letter informing that Nuclear Regulatory Commission has approved sealed source I-125 brachytherapy source for distribution to persons licensed to use byproduct material. (3 page(s), 11/24/1999)
• ML993400089 - Letter informing that Mills Biopharmaceuticals lead safe label and label material supplied by Weber,Arlington Heights,IL. (5 page(s), 11/18/1999)
• ML993400103 - Letter submitting list of items, including request for exemption from bending and tensile tests, request for lower test temperature and accident conditions (36 page(s), 11/30/1999)
• ML993400124 - Reviewed 990802 application requesting sealed sources and devices evaluation and registration of I-125. (3 page(s), 9/23/1999)
• ML993400137 - Forwards raw material specitication sheets for argon,silver shperes,sodium iodine-125 and titanium tubing. (7 page(s), 8/2/1999)
• ML993400249 - Letter forwarding raw material specification sheets for argon,silver spheres,sodium iodine 125 and titanium tubing. (12 page(s), 8/2/1999)
• ML993400260 - Letter forwarding raw material specification sheets for argon,silver spheres,sodium iodine-125 and titanium tubing. (25 page(s), 8/2/1999)
• ML993400369 - Application for sealed source and device evaluation and registration. (1 page(s), 6/13/1999)
• ML993400380 - APPLICATION FOR REGISTRATION OF BRACIIVTHERAPY SEED FOR MEDICAL USE (26 page(s), 11/30/1999)
• ML993400405 - DRAFT QUALITY MANUAL (27 page(s), 6/14/1999)
• ML993400409 - Letter submitting information regarding manufacturing of brachytherapy sources under 10CFR32.74. (1 page(s), 11/12/1999)
• ML993400425 - Letter requesting verification and confirmation that maximum activities including tolerances in 150 mCi of draft registration cerificate provided with application indicates as maximum activity for model 125SH. (20 page(s), 10/1/1999)