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FDA 510(k) Application Details - K052740
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K052740
Device Name
Laparoscope, General & Plastic Surgery
Applicant
CONMED INTEGRATED SYSTEMS (CMIS)
1815 NW 169TH PLACE
SUITE 4020
BEAVERTON, OR 97006 US
Other 510(k) Applications for this Company
Contact
C. JEFF LIPPS
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2005
Decision Date
10/17/2005
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 K052740
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