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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K941467
Device Name WOUND DRESSING KIT
Applicant
Clinical Resources, Inc.
825a Tollgate Rd.
Elgin,  IL  60123
Applicant Contact DAVID INSCO
Correspondent
Clinical Resources, Inc.
825a Tollgate Rd.
Elgin,  IL  60123
Correspondent Contact DAVID INSCO
Regulation Number880.6850
Classification Product Code
FRG  
Date Received03/28/1994
Decision Date 05/12/1994
Decision Substantially Equivalent (SESE)
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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