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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cystoscope and accessories, flexible/rigid
510(k) Number K093665
Device Name ENDO SMARTCAP
Applicant
BYRNE MEDICAL INC.
3150 POLLOK DR
conroe,  TX  77303
Applicant Contact don byrne
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
twinsburg,  OH  44087
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received11/25/2009
Decision Date 12/15/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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