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FDA 510(k) Application Details - K965007
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K965007
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
ORATEC INTERVENTIONS, INC.
3700 HAVEN CT.
MOUNTAIN VIEW, CA 94025 US
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Contact
MICHAEL KWAN, PH.D.
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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
12/16/1996
Decision Date
02/06/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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