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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical patient return electrode
510(k) Number K121268
Device Name WANDY DISPERSVIE ELECTRODE
Original Applicant
BIO-MED USA INC.
111 ellison street
paterson,  NJ  07505
Original Contact young chi
Regulation Number878.4400
Classification Product Code
ODR  
Date Received04/26/2012
Decision Date 12/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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