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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K142480
Device Name OsteoCool V-2 RF Ablation System
Applicant
BAYLIS MEDICAL COMPANY INC.
2645 MATHESON BLVD. EAST
MISSISSAUGA, ONTARIO,  CA L4W 5S4
Applicant Contact MEGHAL KHAKHAR
Correspondent
BAYLIS MEDICAL COMPANY INC.
2645 MATHESON BLVD. EAST
MISSISSAUGA, ONTARIO,  CA L4W 5S4
Correspondent Contact MEGHAL KHAKHAR
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/04/2014
Decision Date 06/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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