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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name guide, surgical, instrument
510(k) Number K842698
Device Name BRITISH SPINAL FUSION SET
Applicant
DOWNS SURGICAL LTD.
803 n. front st. suite 3
mchenry,  IL  60050
Correspondent
DOWNS SURGICAL LTD.
803 n. front st. suite 3
mchenry,  IL  60050
Regulation Number878.4800
Classification Product Code
FZX  
Date Received07/11/1984
Decision Date 09/12/1984
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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