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510(k) K052058

MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL by Fournitures Hospitalieres Industrie — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2005
Date Received
July 29, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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