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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K971202
Device Name COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS
Applicant
Comeg Endoskopie GmbH
13790 E. Rice Place
Aurora,  CO  80015
Applicant Contact PETER DUFFY
Correspondent
Comeg Endoskopie GmbH
13790 E. Rice Place
Aurora,  CO  80015
Correspondent Contact PETER DUFFY
Regulation Number876.1500
Classification Product Code
OCZ  
Subsequent Product Code
FGK  
Date Received04/01/1997
Decision Date 05/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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