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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 K902921
Device Name RAYON NEUROLOGICAL SPONGE
Applicant
AMERICAN SILK SUTURES, INC.
82 SANDERSON AVE.
LYNN,  MA  01902
Applicant Contact WIN HIRSCH
Correspondent
AMERICAN SILK SUTURES, INC.
82 SANDERSON AVE.
LYNN,  MA  01902
Correspondent Contact WIN HIRSCH
Regulation Number882.4700
Classification Product Code
HBA  
Date Received07/03/1990
Decision Date 09/18/1990
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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