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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystometric gas (carbon-dioxide) on hydraulic device
510(k) Number K920451
Device Name ENDOTEK ULTRA SYSTEM
Applicant
SURGITEK
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Applicant Contact WILLIAM H DUFFELL
Correspondent
SURGITEK
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Correspondent Contact WILLIAM H DUFFELL
Regulation Number876.1620
Classification Product Code
FAP  
Date Received02/04/1992
Decision Date 09/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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