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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dislodger, stone, basket, ureteral, metal
510(k) Number K970489
Device Name COMEG ENDOSCOPY GRASPING FORCEPS
Applicant
COMEG ENDOSCOPY
13790 EAST RICE PLACE
AURORA,  CO  80015
Applicant Contact PETER DUFFY
Correspondent
COMEG ENDOSCOPY
13790 EAST RICE PLACE
AURORA,  CO  80015
Correspondent Contact PETER DUFFY
Regulation Number876.4680
Classification Product Code
FFL  
Date Received02/10/1997
Decision Date 03/19/1997
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
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