FDA 510(k) Application Details - K063748

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K063748
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant THERMOSURGERY TECHNOLOGIES, INC.
2901 W. INDIAN SCHOOL RD.
PHOENIX, AZ 85017-4162 US
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Contact GENE ZISCHKE
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 12/19/2006
Decision Date 02/01/2007
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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