FDA Registration
Active
🇨🇦 Canada
LAC-MAC LIMITED
Reg #: 8022129
·
FEI: 6499
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- LAC-MAC LIMITED
- Registration Number
- 8022129
- FEI Number
- 6499
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 847 HIGHBURY AVE, BUILDING No. 2
- City
- LONDON Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K102864
Owner / Operator
- Firm Name
- LAC-MAC LIMITED
- Operator Number
- 8022129
- Address
- 847 HIGHBURY AVE, BUILDING #2
- City
- LONDON
- State
- Ontario
- Postal Code
- N5Y 5B8
- Country
- CA
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 |
|---|---|---|---|---|---|
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2011-03-09 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2024-08-19 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2011-03-10 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2022-03-01 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2007-11-06 |
Proprietary Names
Single Ply Wrapper
Gown non-surgical
R.MOR.Tex LR Surgical Gowns
Gown, Surgical, Level 3
General purpose surgical drape, Reusable, Level 2
Surgical Drape, Level 4
R.MOR.Tex
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device