Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680854

FEI Number

1000494121

Entity Name

KONAN MEDICAL, INC.

City/State/Country

NISHINOMIYA Hyogo, JP

Establishment Address

10-29 MIYANISHI-CHO, NISHINOMIYA Hyogo 662-0976, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KONAN MEDICAL, INC. (Owner Number: 9011976)

Owner / Operator Contact Address

10-29 MIYANISHI-CHO,, NISHINOMIYA, HYOGO, JP-28 662-0976, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191558

PMA Number

N/A

All Registered Proprietary Names

Konan Specular Microscope XX Konan Specular Microscope XVII

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NQE	Microscope, Specular	Ophthalmic	Class 2	886.1850	2020-03-31

Official Correspondent

No official correspondent registered.

US Agent Details

Dale Sadlik Business: Konan Medical USA, Inc. Email: dsadlik@konanmedical.com Phone: (949) 5762200

Related Public Records

Same Entity

KONAN MEDICAL, INC.

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 9680854. Last updated year: 2026. Please use registration number 9680854 when referencing this establishment in official correspondence.