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
Phone
916 8138456

Products

Device Name Product Code
Electrosurgical, Cutting & Coagulation & Accessories GEI

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