FDA 510(k) Application Details - K061292

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K061292
Device Name Laparoscope, General & Plastic Surgery
Applicant KINETIC SURGICAL LLC
2157 VISTA LA NISA
CARLSBAD, CA 92009 US
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Contact JIM CAPUTO
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 05/09/2006
Decision Date 07/03/2006
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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