Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004638277

FEI Number

3004638277

Entity Name

Yoshikawa Kasei Co., Ltd. Medical Company Osaka Plant

City/State/Country

Osaka-shi, JP

Establishment Address

5 Chome 6-34, Yokozutsumi; Tsurumi, Osaka-shi 538-0052, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MIC International (Owner Number: 10087043)

Owner / Operator Contact Address

201 E 69th Street, Suite 5O, New York, NY 10021, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-01-05
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-01-05
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2023-01-21

Official Correspondent

Deno Zachary

US Agent Details

Deno Zachary Business: MIC International Email: dzachary@micinternational.com Phone: (917) 3315789

Related Public Records

Same Entity

MIC International

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014055212	Yoshikawa Kasei Co., Ltd. Medical Company Shizuoka Plant	Fukuroi City Shizuoka, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220587	Olympus Medical Systems Corp.	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	2022-05-11

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3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
9610595	AIZU OLYMPUS CO., LTD.	AIZUWAKAMATSU-SHI Fukushima, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004638277. Last updated year: 2026. Please use registration number 3004638277 when referencing this establishment in official correspondence.