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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K862945
Device Name DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES
Applicant
Downs Surgical , Ltd.
42 Industrial Way
Wilmington,  MA  01887
Applicant Contact JARVIS CRIBB
Correspondent
Downs Surgical , Ltd.
42 Industrial Way
Wilmington,  MA  01887
Correspondent Contact JARVIS CRIBB
Date Received08/05/1986
Decision Date 08/20/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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