FDA 510(k) Application Details - K973205

Device Classification Name Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

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510(K) Number K973205
Device Name Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Applicant WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM, NC 27105 US
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Contact SOPHIA ROUSE
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Regulation Number 876.1500

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Classification Product Code ODD
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Date Received 08/26/1997
Decision Date 11/24/1997
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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