FDA 510(k) Application Details - K013904

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K013904
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO L4W-4T7 CA
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Contact KRIS SHAH
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 11/26/2001
Decision Date 02/12/2002
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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