FDA Registration
Active
🇺🇸 United States
Ambler
Reg #: 3005528784
·
FEI: 3005528784
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ambler Surgical, LLC
- Registration Number
- 3005528784
- FEI Number
- 3005528784
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 436 Creamery Way Ste 300
- City
- EXTON
- State
- PA
- ZIP
- 19341
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112176
Owner / Operator
- Firm Name
- AMBLER SURGICAL, LLC
- Operator Number
- 9106120
- Address
- 436 Creamery Way Ste 300
- City
- Exton
- State
- PA
- Postal Code
- 19341
- Country
- US
- Correspondent
- MARTIN J ANTHONY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Eye Sphere | HPZ | Class 2 | Ophthalmic | No | 2016-06-16 |
Proprietary Names
Ambler
Establishment Types
Repack or Relabel Medical Device