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FDA 510(k) Application Details - K012129
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K012129
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
ORTHO DEVELOPMENT CORP.
106 WEST 12200 SOUTH
DRAPER, UT 84020 US
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Contact
CAROL FREASIER
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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
07/09/2001
Decision Date
08/22/2001
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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