FDA Registration
Active
🇺🇸 United States
Saljet Single Dose Sterile Saline
Reg #: 1424524
·
FEI: 3003036307
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WINCHESTER LABORATORIES, LLLP
- Registration Number
- 1424524
- FEI Number
- 3003036307
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 301 W. Atlantic Avenue, SUITE 01
- City
- Delray Beach
- State
- FL
- ZIP
- 33444
- Country
- US
Regulatory Submissions
- 510(k) Number
- K993969
Owner / Operator
- Firm Name
- WINCHESTER LABORATORIES, LLLP
- Operator Number
- 9041041
- Address
- 301 W. Atlantic Ave., SUITE 1
- City
- Delray Beach
- State
- FL
- Postal Code
- 33444
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2007-12-05 |
Proprietary Names
Saljet Single Dose Sterile Saline
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility