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510(k) K063753

GFX NERVE ABLATION SYSTEM by Aci, Inc. — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2007
Date Received
December 19, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type

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