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.
| Device ID | K142480 |
| 510k Number | K142480 |
| Device Name: | OsteoCool V-2 RF Ablation System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, Ontario, CA L4w 5s4 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, Ontario, CA L4w 5s4 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-04 |
| Decision Date | 2015-06-16 |
| Summary: | summary |