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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 K822916
Device Name UROCOMP REMOTE CONTROL 1804
Applicant
LIFE-TECH INTL., INC.
P.O. BOX 36221
HOUSTON,  TX  77236 -6221
Applicant Contact ALFRED C COATES
Correspondent
LIFE-TECH INTL., INC.
P.O. BOX 36221
HOUSTON,  TX  77236 -6221
Correspondent Contact ALFRED C COATES
Regulation Number876.1620
Classification Product Code
FAP  
Date Received10/01/1982
Decision Date 12/13/1982
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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