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FDA 510(k) Application Details - K121268
Device Classification Name
Electrosurgical Patient Return Electrode
More FDA Info for this Device
510(K) Number
K121268
Device Name
Electrosurgical Patient Return Electrode
Applicant
BIO-MED USA INC.
111 ELLISON STREET
PATERSON, NJ 07505 US
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Contact
YOUNG CHI
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
ODR
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More FDA Info for this Product Code
Date Received
04/26/2012
Decision Date
12/20/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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