FDA 510(k) Application Details - K152059

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K152059
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
35-41 TAI LIN PAI RD., UNIT F, 5TH FL., FOLD KING IND. BLDG,
KWAI CHUNG, N.T.
HONG KONG TW
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Contact THOMAS CHAN TSZ FUNG
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 07/24/2015
Decision Date 04/21/2016
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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