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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 K972196
Device Name OSTEO ANATOMICAL BONE PLATES
Applicant
Osteonics Corp.
59 Route 17
Allendale,,  NJ  07401 -1677
Applicant Contact KATE SUTTON
Correspondent
Osteonics Corp.
59 Route 17
Allendale,,  NJ  07401 -1677
Correspondent Contact KATE SUTTON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received06/10/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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