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510(k) K082399

PECTUS STRUT by Koros USA, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2009
Date Received
August 20, 2008
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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  • K071338 — FLEX ARM RETRACTOR SYSTEM (May 29, 2007)

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