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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K941499
Device Name KIT PAK DRESSING CHANGE TRAY
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 Number880.5240
Classification Product Code
KGX  
Subsequent Product Code
FRG  
Date Received03/29/1994
Decision Date 07/20/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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