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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, surgical, non-powered
510(k) Number K832343
Device Name DERMALAND DURAL HOOKS
Applicant
NATIONAL FABTRONIX, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NATIONAL FABTRONIX, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.4535
Classification Product Code
HAO  
Date Received07/18/1983
Decision Date 08/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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