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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K942959
Device Name KIT PAK WET SALINE DRESSING
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
Classification Product Code
FRO  
Date Received06/23/1994
Decision Date 02/14/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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