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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sheath, corrugated rubber, for nonindwelling catheter, sterile
510(k) Number K934080
Device Name URINARY DRAINAGE BAG
Applicant
KIT PAK, INC.
825 CHASE AVE.
ELK GROVE VILLAGE,  IL  60007
Applicant Contact THOMAS J SANDERS
Correspondent
KIT PAK, INC.
825 CHASE AVE.
ELK GROVE VILLAGE,  IL  60007
Correspondent Contact THOMAS J SANDERS
Regulation Number876.5250
Classification Product Code
EYT  
Date Received08/20/1993
Decision Date 05/18/1994
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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