OSTEOCOOL (TM) RF ABLATION SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K111523
Device Name OSTEOCOOL (TM) RF ABLATION SYSTEM
Applicant
BAYLIS MEDICAL CO., INC.
2645 matheson blvd. e
mississauga, ontario, 

CA

l4w 5s4

Applicant Contact meghal khakhar
Correspondent
BAYLIS MEDICAL CO., INC.
2645 matheson blvd. e
mississauga, ontario, 

CA

l4w 5s4

Correspodent Contact meghal khakhar
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 06/01/2011
Decision Date 03/13/2012
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