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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name resectoscope
510(k) Number K971881
Device Name COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS
Applicant
COMEG ENDOSCOPY
13790 EAST RICE PLACE
AURORA,  CO  80015
Applicant Contact KAELYN HADLEY
Correspondent
COMEG ENDOSCOPY
13790 EAST RICE PLACE
AURORA,  CO  80015
Correspondent Contact KAELYN HADLEY
Regulation Number876.1500
Classification Product Code
FJL  
Subsequent Product Codes
EZO   FAS   FDC  
Date Received05/20/1997
Decision Date 08/12/1997
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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