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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Microsurgical
510(k) Number K873933
Device Name RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM
Applicant
Downs Surgical , Ltd.
42 Industrial Way
Wilmington,  MA  01887
Applicant Contact MR. J FORSTER
Correspondent
Downs Surgical , Ltd.
42 Industrial Way
Wilmington,  MA  01887
Correspondent Contact MR. J FORSTER
Regulation Number882.4525
Classification Product Code
GZX  
Date Received09/25/1987
Decision Date 12/17/1987
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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