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510(k) K093327

INTCO TAB ELECTRODE by Shanghai Intco Electrode Manufacturing Co., Ltd. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2010
Date Received
October 26, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type

Other clearances by Shanghai Intco Electrode Manufacturing Co., Ltd.

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