FDA 510(k) Application Details - K120061

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K120061
Device Name Laparoscope, General & Plastic Surgery
Applicant COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 Middletown Ave
North Haven, CT 06473 US
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Contact JOSEPH CANAVAN
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 01/09/2012
Decision Date 03/27/2012
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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