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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K853709
Device Name A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM
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
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/04/1985
Decision Date 11/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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