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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 K863169
Device Name MODEL AS-72 ADMINISTRATION SET
Applicant
LIFE-TECH INTL., INC.
P.O. BOX 36221
HOUSTON,  TX  77236 -6221
Applicant Contact COATS, MD
Correspondent
LIFE-TECH INTL., INC.
P.O. BOX 36221
HOUSTON,  TX  77236 -6221
Correspondent Contact COATS, MD
Regulation Number876.1620
Classification Product Code
FAP  
Date Received08/18/1986
Decision Date 09/09/1986
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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