FDA 510(k) Application Details - K040780

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K040780
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant HANGZHOU SHUYOU MEDICAL INSTRUMENT COMPANY, LTD.
6868 COLONY DRIVE
WEST BLOOMFIELD, MI 48323 US
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Contact JIAN CHEN, M.D.
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 03/26/2004
Decision Date 02/10/2005
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 N
Expedited Review



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