Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011500374

FEI Number

3011500374

Entity Name

TOP CORPORATION OHMASU PLANT

City/State/Country

ISHIOKA Ibaraki, JP

Establishment Address

1-5 OHMASU,, ISHIOKA Ibaraki 315-0101, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TOP CORPORATION (Owner Number: 8030272)

Owner / Operator Contact Address

19-10 SENJU, NAKAI-CHO, ADACHI-KU, JP-13 120-0035, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K843415

PMA Number

N/A

All Registered Proprietary Names

TOP HYPODERMIC SYRINGE LUER LOCK NRFit Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-03-02

Official Correspondent

Yuki HANAWA

US Agent Details

Nicholas J. Mazza Business: Mazza Healthcare Email: nmazza@mazzahealthcare.com Phone: (847) 2823446

Related Public Records

Same Entity

TOP CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005301868	TOP SURGICAL TAIWAN CORP.	TA LIAO HSIANG, KAOHSIUNG HSIEN, TW
1000587249	MEDITOP CORPORATION (M) SDN BHD	BARU BANGI,SELANGOR DARUL EHSA, MY
9610993	TOP CORPORATION	ADACHI-KU Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011500374. Last updated year: 2026. Please use registration number 3011500374 when referencing this establishment in official correspondence.