FDA Registration
Active
🇺🇸 United States
SMOOTH-BOR PLASTICS
Reg #: 3006666710
·
FEI: 3006666710
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- SMOOTH-BOR PLASTICS
- Registration Number
- 3006666710
- FEI Number
- 3006666710
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 23322 del Lago Dr.
- City
- Laguna Hills
- State
- CA
- ZIP
- 92653
- Country
- US
Owner / Operator
- Firm Name
- Smooth-Bor Plastics
- Operator Number
- 10057072
- Address
- 23322 del Lago Dr.
- City
- Laguna Hills
- State
- CA
- Postal Code
- 92653
- Country
- US
- Correspondent
- Eric Carlson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2018-02-16 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2022-06-14 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2023-04-28 |
Proprietary Names
AltaFlex
InCourage
Air Tubing Grey
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device