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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 K854714
Device Name X-RAY DETECTABLE COTTON BALLS
Applicant
AMERICAN SILK SUTURES, INC.
P.O. BOX 370
LEDYARD,  CT  06339
Correspondent
AMERICAN SILK SUTURES, INC.
P.O. BOX 370
LEDYARD,  CT  06339
Regulation Number878.4450
Classification Product Code
GDY  
Date Received11/22/1985
Decision Date 12/17/1985
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
Recalls CDRH Recalls
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