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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, ceiling mounted
510(k) Number K031979
Device Name CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
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 Number878.4580
Classification Product Code
FSY  
Subsequent Product Codes
FET   GCJ   GEI   HET   HIF  
LMC  
Date Received06/26/2003
Decision Date 07/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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