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510(k) K121268

WANDY DISPERSVIE ELECTRODE by Bio-Med USA, Inc. — Product Code ODR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2012
Date Received
April 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical Patient Return Electrode
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

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