FDA 510(k) Application Details - K112659

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K112659
Device Name Laparoscope, General & Plastic Surgery
Applicant SURGICAL INNOVATIONS PLC
CLAYTON WOOD HOUSE,
6 CLAYTON WOOD BANK
LEEDS, WEST YORKSHIRE LS16 6ZQ GB
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Contact STEPHEN SEED
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 09/13/2011
Decision Date 03/09/2012
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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