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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name splint, nasal
510(k) Number K872905
Device Name AMERICAN NASAL 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 Number874.5800
Classification Product Code
EPP  
Date Received07/24/1987
Decision Date 09/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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