FDA 510(k) Application Details - K060717

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K060717
Device Name Laparoscope, General & Plastic Surgery
Applicant CONMED INTEGRATED SYSTEMS (CMIS)
1815 NW 169TH PLACE
SUITE 4020
BEAVERTON, OR 97006 US
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Contact C. JEFF LIPPS
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 03/17/2006
Decision Date 04/25/2006
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 N
Expedited Review

FDA Source Information for K060717


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