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510(k) K043602

QUADRANT RETRACTOR SYSTEM by Medtronic Sofamor Danek — Product Code GAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2005
Date Received
December 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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