FDA Registration
Active
🇺🇸 United States
MESIRE - Balloon Sinus Dilatation System
Reg #: 3012167431
·
FEI: 3012167431
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MERIL INC
- Registration Number
- 3012167431
- FEI Number
- 3012167431
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2436 Emrick Boulevard
- City
- Bethlehem
- State
- PA
- ZIP
- 18020
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172737
Owner / Operator
- Firm Name
- Meril Inc
- Operator Number
- 10049695
- Address
- 2436 Emrick Boulevard
- City
- Bethlehem
- State
- PA
- Postal Code
- 18020
- Country
- US
- Correspondent
- Kaiyumkhan Patel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2018-12-31 |
Proprietary Names
MESIRE - Balloon Sinus Dilatation System
Establishment Types
Complaint File Establishment per 21 CFR 820.198