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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K052740
Device Name NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
Applicant
CONMED INTEGRATED SYSTEMS (CMIS)
1815 NW 169TH PLACE
SUITE 4020
BEAVERTON,  OR  97006
Applicant Contact C. JEFF LIPPS
Correspondent
CONMED INTEGRATED SYSTEMS (CMIS)
1815 NW 169TH PLACE
SUITE 4020
BEAVERTON,  OR  97006
Correspondent Contact C. JEFF LIPPS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/30/2005
Decision Date 10/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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