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FDA 510(k) Application Details - K100711
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K100711
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
ENCISION, INC.
6797 WINCHESTER CIR.
BOULDER, CO 80301 US
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Contact
JUDITH V KING
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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
03/12/2010
Decision Date
06/09/2010
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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