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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
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