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510(k) K022370

FRAMELOCK; FRAMELOCK ACCESSORIES by Medtronic Xomed, Inc. — Product Code HBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2002
Date Received
July 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Manual)
Device Class
Class II
Regulation Number
882.4300
Review Panel
NE
Submission Type

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