FDA 510(k) Application Details - K963046

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K963046
Device Name Laparoscope, General & Plastic Surgery
Applicant CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA, FL 33612 US
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Contact JACK THOMAS
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 08/05/1996
Decision Date 11/01/1996
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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