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FDA 510(k) Application Details - K963993
Device Classification Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
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510(K) Number
K963993
Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant
RUSCH, INC.
TALL PINES PARK
JAFFREY, NH 03452 US
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Contact
NEIL R ARMSTRONG
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Regulation Number
876.5130
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Classification Product Code
FCM
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More FDA Info for this Product Code
Date Received
10/04/1996
Decision Date
12/17/1996
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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