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510(k) K051155

SOLCO 4CIS GENERAL PLATE SYSTEM by Solco Biomedical Co., Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2005
Date Received
May 4, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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