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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 K854713
Device Name COTTON NEUROLOGICAL SPONGE
Applicant
American Silk Sutures, Inc.
P.O. Box 370
Ledyard,  CT  06339
Applicant Contact MILLER
Correspondent
American Silk Sutures, Inc.
P.O. Box 370
Ledyard,  CT  06339
Correspondent Contact MILLER
Regulation Number882.4700
Classification Product Code
HBA  
Date Received11/22/1985
Decision Date 03/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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