FDA 510(k) Application Details - K962670

Device Classification Name System, Irrigation, Urological

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510(K) Number K962670
Device Name System, Irrigation, Urological
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 000.0000

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Classification Product Code LJH
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Date Received 07/09/1996
Decision Date 08/14/1996
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

FDA Source Information for K962670


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