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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 K050829
Device Name NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
Applicant
Conmed Integrated Systems (Cmis)
1815 NW 169th Pl.
Suite 4020
Beaverton,  OR  97006
Applicant Contact C. JEFF LIPPS
Correspondent
Conmed Integrated Systems (Cmis)
1815 NW 169th Pl.
Suite 4020
Beaverton,  OR  97006
Correspondent Contact C. JEFF LIPPS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/01/2005
Decision Date 05/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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