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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 K882708
Device Name GAUZE SPONGE, X-RAY DETECTABLE
Applicant
Bioseal
350 N. Palm
Brea,  CA  92621
Applicant Contact WILLIAM L RUNION
Correspondent
Bioseal
350 N. Palm
Brea,  CA  92621
Correspondent Contact WILLIAM L RUNION
Regulation Number878.4450
Classification Product Code
GDY  
Date Received06/27/1988
Decision Date 08/03/1988
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
Recalls CDRH Recalls
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