FDA 510(k) Application Details - K092634

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K092634
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO
BUILDING 1, NO.1, HUIMIN EAST
RD HUICHENG TOWN, XINHUI DISTR
JIANGMEN GUANG DONG 529100 CN
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Contact CHEN XI
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 08/27/2009
Decision Date 12/01/2009
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 Y
Expedited Review



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