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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K871387
Device Name SECOND NATURE(TM)
Applicant
ADVANCED CLINICAL PRODUCTS, INC.
3346 WALNUT BEND LN.
HOUSTON,  TX  77042
Applicant Contact GENE L MRAVA
Correspondent
ADVANCED CLINICAL PRODUCTS, INC.
3346 WALNUT BEND LN.
HOUSTON,  TX  77042
Correspondent Contact GENE L MRAVA
Regulation Number876.5250
Classification Product Code
KNX  
Date Received04/07/1987
Decision Date 05/29/1987
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
Recalls CDRH Recalls
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