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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing Kit
510(k) Number K923905
Device Name WOUND DRESSING KIT
Applicant
Kit Pak, Inc.
825 Chase Ave.
Elk Grove Village,  IL  60007
Applicant Contact THOMAS SANDERS
Correspondent
Kit Pak, Inc.
825 Chase Ave.
Elk Grove Village,  IL  60007
Correspondent Contact THOMAS SANDERS
Regulation Number880.5075
Classification Product Code
MCY  
Date Received08/04/1992
Decision Date 07/02/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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