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FDA 510(k) Application Details - K082204
Device Classification Name
Electrosurgical Patient Return Electrode
More FDA Info for this Device
510(K) Number
K082204
Device Name
Electrosurgical Patient Return Electrode
Applicant
VENTLAB CORP.
1676 VILLAGE GREEN STE A
CROFTON, MD 21114-4341 US
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Contact
CHRISTINA NORRIS
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
ODR
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More FDA Info for this Product Code
Date Received
08/05/2008
Decision Date
08/13/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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