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510(k) K052444

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM by Inion , Ltd. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2005
Date Received
September 6, 2005
Clearance Type
Special
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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