FDA 510(k) Application Details - K132374

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K132374
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant BAYLIS MEDICAL COMPANY INC.
2645 MATHESON BLVD. EAST
MISSISSAUGA, ONTARIO L4W 5S4 CA
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Contact MEGHAL KHAKHAR
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 07/30/2013
Decision Date 08/30/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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