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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K970764
Device Name COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES
Applicant
Comeg Endoscopy
13790 E. Rice Pl.
Aurora,  CO  80015
Applicant Contact KAELYN HADLEY
Correspondent
Comeg Endoscopy
13790 E. Rice Pl.
Aurora,  CO  80015
Correspondent Contact KAELYN HADLEY
Regulation Number876.1500
Classification Product Code
OCX  
Date Received03/03/1997
Decision Date 04/22/1997
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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