FDA 510(k) Application Details - K960148

Device Classification Name Stent, Ureteral

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510(K) Number K960148
Device Name Stent, Ureteral
Applicant CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE, PA 19047 US
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Contact TODD J POLK
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Regulation Number 876.4620

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Classification Product Code FAD
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Date Received 01/11/1996
Decision Date 03/25/1996
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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