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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.
PARKWAY CLOSE,PARKWAY
INDUSTRIAL ESTATE
SHEFFIELD S9 4WJ,  GB
Applicant Contact GEOFFREY W DOWN
Correspondent
DOWNS SURGICAL LTD.
PARKWAY CLOSE,PARKWAY
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
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