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FDA 510(k) Application Details - K142229
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K142229
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
DOMAIN SURGICAL, INC.
1370 SOUTH 2100 EAST
SALT LAKE CITY, UT 84108 US
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CURTIS JENSEN
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Regulation Number
878.4400
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Classification Product Code
GEI
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Date Received
08/13/2014
Decision Date
01/02/2015
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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