OsteoCool V-2 RF Ablation System

Electrosurgical, Cutting & Coagulation & Accessories

BAYLIS MEDICAL COMPANY INC.

The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Osteocool V-2 Rf Ablation System.

Pre-market Notification Details

Device IDK142480
510k NumberK142480
Device Name:OsteoCool V-2 RF Ablation System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, Ontario,  CA L4w 5s4
ContactMeghal Khakhar
CorrespondentMeghal Khakhar
BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, Ontario,  CA L4w 5s4
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-04
Decision Date2015-06-16
Summary:summary

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