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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 K842572
Device Name GAUZE & LAB SPONGES STERILE & NON
Applicant
ULTI-MED INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ULTI-MED INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4450
Classification Product Code
GDY  
Date Received07/03/1984
Decision Date 08/15/1984
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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