FDA 510(k) Application Details - K960215

Device Classification Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter

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510(K) Number K960215
Device Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant CUSTOM PACK RELIABILITY
4207 VINELAND ROAD, M-1
ORLANDO, FL 32811 US
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Contact RICHARD L ELLWOOD
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Regulation Number 876.5130

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Classification Product Code FCM
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Date Received 01/16/1996
Decision Date 04/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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