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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K944879
Device Name GAUZE SPONGES
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 Number878.4450
Classification Product Code
GDY  
Date Received10/03/1994
Decision Date 12/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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