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FDA 510(k) Application Details - K962254
Device Classification Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
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510(K) Number
K962254
Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant
NATIONAL HEALTHCARE MFG. CORP.
251 SAULTEAUX CRESCENT
WINNIPEG, MANITOBA R3J 3C7 CA
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BOB JACKSON
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Regulation Number
876.5130
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Classification Product Code
FCM
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Date Received
06/12/1996
Decision Date
07/29/1996
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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