FDA 510(k) Application Details - K960878

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K960878
Device Name Laparoscope, General & Plastic Surgery
Applicant COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER, IN 47460 US
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Contact RICK LYKINS
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 03/04/1996
Decision Date 03/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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