OsteoCool V-3 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-3 Rf Ablation System.

Pre-market Notification Details

Device IDK152057
510k NumberK152057
Device Name:OsteoCool V-3 RF Ablation System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga,  CA L4w 5s4
ContactMeghal Khakhar
CorrespondentMeghal Khakhar
BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga,  CA L4w 5s4
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-24
Decision Date2015-11-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169871625 K152057 000
00763000167639 K152057 000
00643169578906 K152057 000
00643169578913 K152057 000
00643169578920 K152057 000
00643169546219 K152057 000
00643169546226 K152057 000
00643169546233 K152057 000
00643169546264 K152057 000
00643169546301 K152057 000
00643169546394 K152057 000
00643169546400 K152057 000
00643169546462 K152057 000
00643169585652 K152057 000
00643169585669 K152057 000
00643169641211 K152057 000
00643169674714 K152057 000
00643169871618 K152057 000
00763000157845 K152057 000

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