FDA Registration
Active
🇮🇳 India
Valleylab Button Switch Pencil, E2516, E2516GNSB, and E2516NSB
Reg #: 3018094310
·
FEI: 3018094310
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Medtronic Engineering and Innovation Center (MEIC)
- Registration Number
- 3018094310
- FEI Number
- 3018094310
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BSR Tech Park, Survey No.135, 138, 141 & 142 Nanakramguda Main Road
- City
- Hyderabad
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K813071
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
US Agent
- Business Name
- MEDTRONIC, INC.
- Contact Name
- Tania Pearson
- Address
- 3576 Unocal Pl
- City
- Santa Rosa
- State
- CA
- ZIP
- 95403
- Country
- US
- [email protected]
- Phone
- 916 8138456
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-02-02 |
Proprietary Names
Valleylab Button Switch Pencil, E2516, E2516GNSB, and E2516NSB
Valleylab Rocker Switch Pencil Needle Electrode, Holster, E2515HDA and E2515HDANSB
Valleylab Button Switch Pencil Needle Electrode, Holster, E2516HDA
Electrodes
Valleylab Rocker Switch Pencil Holster, E2515H, E2515HDB, E2515HDBNSB, E2515HGNSB, and E2515HNSB
Valleylab Button Switch Pencil Holster, E2516H, E2516HGNSB, and E2516HNSB
Valleylab Rocker Switch Pencil, E2515, E2515NSB, and E2515GNSB
Establishment Types
Complaint File Establishment per 21 CFR 820.198