FDA 510(k) Application Details - K070712

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K070712
Device Name Laparoscope, General & Plastic Surgery
Applicant SURGICAL INNOVATIONS GROUP PLC
CLAYTON PARK CLAYTON WOOD RISE
LEEDS LS16,6RF GB
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Contact STUART MORAN
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 03/14/2007
Decision Date 03/28/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party Y
Expedited Review



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