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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometer, Electrical Recording
510(k) Number K931282
Device Name VOLUME TRANSDUCER
Applicant
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Applicant Contact ALFRED C COATS
Correspondent
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236
Correspondent Contact ALFRED C COATS
Regulation Number876.1620
Classification Product Code
EXQ  
Date Received03/12/1993
Decision Date 09/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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