FDA 510(k) Application Details - K120116

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K120116
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant THERMEDICAL
1835 MARKET STREET
29TH FLOOR
PHILADELPHIA, PA 19103 US
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Contact JANICE M HOGAN
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 01/13/2012
Decision Date 10/01/2012
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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