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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 K881736
Device Name SURGITEK CO2 DELIVERY SYSTEM
Applicant
MEDICAL ENGINEERING CORP.
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Applicant Contact WAXBERG
Correspondent
MEDICAL ENGINEERING CORP.
3037 MT. PLEASANT ST.
RACINE,  WI  53404
Correspondent Contact WAXBERG
Regulation Number876.1620
Classification Product Code
FAP  
Date Received04/22/1988
Decision Date 08/11/1988
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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