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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Contact 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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