FDA Registration
Active
🇺🇸 United States
RESET
Reg #: 3033280591
·
FEI: 3033280591
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HARVEST BIO LLC
- Registration Number
- 3033280591
- FEI Number
- 3033280591
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 101 Centerpoint Dr Ste 105
- City
- Middletown
- State
- CT
- ZIP
- 06457
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN160018
Owner / Operator
- Firm Name
- Harvest Bio
- Operator Number
- 10091901
- Address
- 101 Centerpoint Drive - Ste 105
- City
- Middletown
- State
- CT
- Postal Code
- 06457
- Country
- US
- Correspondent
- Tyler Countie
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computerized Behavioral Therapy Device For Substance Use Disorders | PWE | Class 2 | Neurology | No | 2024-11-14 |
Proprietary Names
RESET
Establishment Types
Manufacture Medical Device