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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 K884826
Device Name GAUZE SPONGE
Applicant
Medical Action Industries, Inc.
1934 New Hwy.
Farmingdale,  NY  11735
Applicant Contact JOHN GIAGU
Correspondent
Medical Action Industries, Inc.
1934 New Hwy.
Farmingdale,  NY  11735
Correspondent Contact JOHN GIAGU
Classification Product Code
EFQ  
Date Received11/18/1988
Decision Date 12/22/1988
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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