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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 K801768
Device Name CONTAIN X-RAY DETECTABLE LAP SPONGE
Applicant
THE BUCKEYE CELLULOSE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
THE BUCKEYE CELLULOSE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4450
Classification Product Code
GDY  
Date Received07/28/1980
Decision Date 08/20/1980
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
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