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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name garment, protective, for incontinence
510(k) Number K932310
Device Name KIT PAK INCONTINENT SKIN CARE KIT
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 Number876.5920
Classification Product Code
EYQ  
Date Received05/11/1993
Decision Date 06/01/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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