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510(k) K003848

HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST by Howmedica Osteonics Corp. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2001
Date Received
December 12, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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