FDA Registration
Active
🇨🇦 Canada
OsteoCool RF Ablation Probe Kit
Reg #: 3020968442
·
FEI: 3020968442
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BAYLIS MEDICAL TECHNOLOGIES INC.
- Registration Number
- 3020968442
- FEI Number
- 3020968442
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2645 Matheson Blvd E
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K161949
Owner / Operator
- Firm Name
- Baylis Medical Technologies Inc.
- Operator Number
- 10082721
- Address
- 2645 Matheson Blvd E
- City
- Mississauga
- State
- Ontario
- Postal Code
- L4W5S4
- Country
- CA
- Correspondent
- Meghal Khakhar
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-01-05 |
Proprietary Names
OsteoCool RF Ablation Probe Kit
OsteoCool Independent Thermocouple Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)