FDA Registration Active 🇫🇷 France

Wide Angle Fiber Optic Probe, Ocutome 5 mm connector

Reg #: 3002991496 · FEI: 3002991496 · Expires 2025
Products
1
Proprietary Names
11
Establishment Types
2
Classifications
1

Registration Details

Registration Name
FCI FRANCE CHIRURGIE INSTRUMENTATION
Registration Number
3002991496
FEI Number
3002991496
Status
Active
Expiry Year
2025
Initial Importer
No
Address
20-22 RUE LOUIS ARMAND
City
PARIS Ile-de-France
Country
FR

Regulatory Submissions

510(k) Number
K982462

Owner / Operator

Firm Name
Carl Zeiss Meditec, Inc.
Operator Number
9053564
Address
5300 Central Parkway
City
Dublin
State
CA
Postal Code
94568
Country
US

US Agent

Business Name
CARL ZEISS MEDITEC USA, INC.
Contact Name
Paul Swift
Address
5300 Central Parkway
City
Dublin
State
CA
ZIP
94568
Country
US
Phone
817 9258507

Products

Device Name Product Code
Image, Illumination, Fiberoptic, For Endoscope FFS

Proprietary Names

Wide Angle Fiber Optic Probe, Ocutome 5 mm connector Wide Angle Fiber Optic Probe, Bausch & Lomb Stellaris PC Chandelier with Adjustable ring, Alcon Constellation Wide Angle Fiber Optic Probe, Bausch & Lomb Focus Fiber Optic Probe, Bausch & Lomb Millenium Chandelier with Adjustable ring, Ocutome 5 mm connector Chandelier with Adjustable ring, Bausch & Lomb Stellaris PC Fiber Optic Probe, Ocutome 5 mm connector Wide Angle Fiber Optic Probe, Alcon Accurus Shielded Fiber Optic Probe, Ocutome 5 mm connector Focus Fiber Optic Probe, Alcon Accurus

Establishment Types

Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device