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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 K874630
Device Name RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS
Applicant
Downs Surgical , Ltd.
42 Industrial Way
Wilmington,  MA  01887
Applicant Contact FORSTER
Correspondent
Downs Surgical , Ltd.
42 Industrial Way
Wilmington,  MA  01887
Correspondent Contact FORSTER
Regulation Number882.4535
Classification Product Code
HAO  
Date Received11/10/1987
Decision Date 12/23/1987
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
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