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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
510(k) Number K945019
Device Name FLUFF GAUXZE ROLL
Applicant
Clinical Resources, Inc.
825a Tollgate Rd.
Elgin,  IL  60123
Applicant Contact INSCO
Correspondent
Clinical Resources, Inc.
825a Tollgate Rd.
Elgin,  IL  60123
Correspondent Contact INSCO
Classification Product Code
EFQ  
Date Received10/12/1994
Decision Date 12/23/1994
Decision Substantially Equivalent (SESE)
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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