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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 K880278
Device Name MALLEABLE PTFE COATED BRAIN SPATULAE
Applicant
Downs Surgical , Ltd.
Pkwy. Close,Pkwy.
Industrial Estate
Sheffield S9 4wj,  GB
Applicant Contact GEOFFREY W DOWN
Correspondent
Downs Surgical , Ltd.
Pkwy. Close,Pkwy.
Industrial Estate
Sheffield S9 4wj,  GB
Correspondent Contact GEOFFREY W DOWN
Regulation Number882.4535
Classification Product Code
HAO  
Date Received01/22/1988
Decision Date 02/11/1988
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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