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510(k) K984230

OSTEO-MESH TM-300 by Osteogenics Biomedical, Inc. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1999
Date Received
November 25, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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