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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 K930697
Device Name MEDLINE STERILE GAUZE SPONGES
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact DONALD BARHAM
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact DONALD BARHAM
Regulation Number878.4450
Classification Product Code
GDY  
Subsequent Product Codes
EFQ   FRO   NAB  
Date Received02/10/1993
Decision Date 06/24/1993
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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