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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 K894505
Device Name COTOLIN DRAIN SPONGE AND DRESSING SPONGE
Applicant
James River Corp.
1915 Marathon Ave.
Neenah,  WI  54956
Applicant Contact RICHARD L DAVIS
Correspondent
James River Corp.
1915 Marathon Ave.
Neenah,  WI  54956
Correspondent Contact RICHARD L DAVIS
Classification Product Code
EFQ  
Date Received07/19/1989
Decision Date 09/15/1989
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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