FDA 510(k) Application Details - K960949

Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter

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510(K) Number K960949
Device Name Collector, Urine, (And Accessories) For Indwelling Catheter
Applicant BRISTOL-MYERS SQUIBB
100 HEADQUARTERS PARK DR.
SKILLMAN, NJ 08558 US
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Contact SUSIE MERCHANT
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Regulation Number 876.5250

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Classification Product Code KNX
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Date Received 03/11/1996
Decision Date 04/19/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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