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.
| Device ID | K152057 |
| 510k Number | K152057 |
| Device Name: | OsteoCool V-3 RF Ablation System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, CA L4w 5s4 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, 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 | 2015-07-24 |
| Decision Date | 2015-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 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 |