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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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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