Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680820

FEI Number

3008849848

Entity Name

SPECWELL CORPORATION

City/State/Country

SETAGAYA-KU Tokyo, JP

Establishment Address

1-18-14 AKATSUTSUMI, SETAGAYA-KU Tokyo 156-0044, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Specwell Corp (Owner Number: 9011738)

Owner / Operator Contact Address

1-18-14 AKATSUTSUMI, SETAGAYA-KU, TOKYO, JP-NOTA 156-0044, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Walters SPECWELL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKB	Telescope, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5870	1994-10-24

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Specwell Corp

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680820. Last updated year: 2026. Please use registration number 9680820 when referencing this establishment in official correspondence.