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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
510(k) Number K882714
Device Name URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450
Applicant
Lsl Industries, Inc.
7383 N. Rogers Ave.
Chicago,  IL  60626
Applicant Contact ASH LUTHRA
Correspondent
Lsl Industries, Inc.
7383 N. Rogers Ave.
Chicago,  IL  60626
Correspondent Contact ASH LUTHRA
Regulation Number876.5250
Classification Product Code
EYZ  
Date Received07/01/1988
Decision Date 01/31/1989
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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