FDA 510(k) Application Details - K013416

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K013416
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant INTUITIVE SURGICAL, INC.
1340 WEST MIDDLEFIELD RD.
MOUNTAIN VIEW, CA 94043 US
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Contact MICHAEL YRAMATEGUI
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 10/15/2001
Decision Date 01/10/2002
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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