FDA Registration
Active
🇨🇦 Canada
Xpan Universal Trocar System
Reg #: 3027500817
·
FEI: 3027500817
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- XPAN INC.
- Registration Number
- 3027500817
- FEI Number
- 3027500817
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 57 Corstate Avenue, Suite 200
- City
- Vaughan Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K223562
Owner / Operator
- Firm Name
- Xpan Inc.
- Operator Number
- 10088252
- Address
- 57 Corstate Avenue, Suite 200
- City
- Vaughan
- State
- Ontario
- Postal Code
- L4K4Y2
- Country
- CA
- Correspondent
- Zaid Atto
US Agent
- Business Name
- Lakeshore Medical Device Consulting LLC
- Contact Name
- Michele Lucey
- Address
- 128 Blye Hill Landing
- City
- Newbury
- State
- NH
- ZIP
- 03255
- Country
- US
- [email protected]
- Phone
- 603 7481374
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-06-26 |
Proprietary Names
Xpan Universal Trocar System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility