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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 K872807
Device Name NON-WOVEN TRACHEOTOMY SPONGE
Applicant
AMERICAN SILK SUTURES, INC.
57 MUNROE ST.
LYNN,  MA  01901
Applicant Contact ED GREENSPAN
Correspondent
AMERICAN SILK SUTURES, INC.
57 MUNROE ST.
LYNN,  MA  01901
Correspondent Contact ED GREENSPAN
Regulation Number878.4450
Classification Product Code
GDY  
Date Received07/14/1987
Decision Date 08/04/1987
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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