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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Cystometric, Hydraulic
510(k) Number K954315
Device Name PVC ABDOMINAL/RECTAL PRESSURE CATHETER
Applicant
LIFE-TECH INTL., INC.
P.O. BOX 36221
HOUSTON,  TX  77236 -6221
Applicant Contact ALFRED C COATS
Correspondent
LIFE-TECH INTL., INC.
P.O. BOX 36221
HOUSTON,  TX  77236 -6221
Correspondent Contact ALFRED C COATS
Regulation Number876.1620
Classification Product Code
FEN  
Date Received09/15/1995
Decision Date 11/30/1995
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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