FDA 510(k) Application Details - K091672

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K091672
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant SHUYOU ELECTRIC MEDICAL SCIENCE CO., LTD.
SUITE 8D, NO.19, LANE 999
ZHONGSHAN NO.2 ROAD(S)
SHANGHAI 200030 CN
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Contact Diana Hong
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 06/09/2009
Decision Date 12/04/2009
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 N
Expedited Review



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