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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Uroflowmeter
510(k) Number K872077
Device Name MODEL 1858 CAVRO/PRESSURE MODULE
Applicant
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236 -6221
Applicant Contact ALFRED C COATS,M.D.
Correspondent
Life-Tech Intl., Inc.
P.O. Box 36221
Houston,  TX  77236 -6221
Correspondent Contact ALFRED C COATS,M.D.
Regulation Number876.1800
Classification Product Code
EXY  
Date Received05/29/1987
Decision Date 08/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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