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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 K944881
Device Name SKIN SCRUB TRAY
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  
Subsequent Product Code
KDD  
Date Received10/03/1994
Decision Date 12/27/1994
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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