FDA 510(k) Application Details - K013165

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K013165
Device Name Laparoscope, General & Plastic Surgery
Applicant CIRCON ACMI
300 STILLWATER AVE.
P.O. BOX 1971
STAMFORD, CT 06904-1971 US
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Contact WAYNE B STERNER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 09/21/2001
Decision Date 01/18/2002
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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