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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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More FDA Info for this Product Code
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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