FDA 510(k) Application Details - K051956

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K051956
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant SOMETECH INCORPORATED
2F, BYUKSAN DIGITAL VALLEY III
212-13, GURODONG, GURO-KU
SEOUL 152-050 KR
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Contact YOUNG-SOO SEOL
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 07/19/2005
Decision Date 09/08/2005
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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