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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 K853936
Device Name 1351 UROFLOW AUTO START
Applicant
LIFE-TECH INTL., INC.
10515 HARWIN DR.
P.O.B OX 36221
HOUSTON,  TX  77036
Applicant Contact ALFRED C COATS
Correspondent
LIFE-TECH INTL., INC.
10515 HARWIN DR.
P.O.B OX 36221
HOUSTON,  TX  77036
Correspondent Contact ALFRED C COATS
Regulation Number876.1620
Classification Product Code
FAP  
Date Received09/24/1985
Decision Date 12/02/1985
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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