FDA 510(k) Application Details - K082204

Device Classification Name Electrosurgical Patient Return Electrode

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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
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Regulation Number 878.4400

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Classification Product Code ODR
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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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