FDA Registration
Active
🇺🇸 United States
RELiZORB®
Reg #: 3009596666
·
FEI: 3009596666
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Alcresta Therapeutics, Inc.
- Registration Number
- 3009596666
- FEI Number
- 3009596666
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 130 Turner Street, Building 3, Suite 200
- City
- Waltham
- State
- MA
- ZIP
- 02453
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232784
Owner / Operator
- Firm Name
- Alcresta Therapeutics, Inc.
- Operator Number
- 10050687
- Address
- 130 Turner Street, Building 3, Suite 200
- City
- Waltham
- State
- MA
- Postal Code
- 02453
- Country
- US
- Correspondent
- Aparajit Panda
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Packed Cartridge | PLQ | Class 2 | Gastroenterology, Urology | No | 2024-05-06 |
Proprietary Names
RELiZORB®
Establishment Types
Manufacture Medical Device