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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
Applicant
BIO-MED USA INC.
111 ELLISON STREET
PATERSON,  NJ  07505
Applicant Contact YOUNG CHI
Correspondent
BIO-MED USA INC.
111 ELLISON STREET
PATERSON,  NJ  07505
Correspondent Contact YOUNG CHI
Regulation Number878.4400
Classification Product Code
ODR  
Date Received04/26/2012
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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