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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, Pediatric, For Indwelling Catheter
510(k) Number K896581
Device Name PEDIATRIC DRAIN BAG
Applicant
LAYTECH MEDICAL CO.
816 NICHOLS
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact CATHERINE S LAYTON
Correspondent
LAYTECH MEDICAL CO.
816 NICHOLS
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact CATHERINE S LAYTON
Regulation Number876.5250
Classification Product Code
FFH  
Date Received11/17/1989
Decision Date 01/31/1990
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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