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510(k) K101592

ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM by Cheng Medical, Corporation — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2011
Date Received
June 7, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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