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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name neurosurgical paddie
510(k) Number K862494
Device Name POLYESTER SPONGE PATTIE
Applicant
AMERICAN SILK SUTURES, INC.
91 NASON RD.
SWAMPSCOTT,  MA  01907
Applicant Contact ED GREENSPAN
Correspondent
AMERICAN SILK SUTURES, INC.
91 NASON RD.
SWAMPSCOTT,  MA  01907
Correspondent Contact ED GREENSPAN
Regulation Number882.4700
Classification Product Code
HBA  
Date Received07/01/1986
Decision Date 07/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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