Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610993

FEI Number

3002808374

Entity Name

TOP CORPORATION

City/State/Country

ADACHI-KU Tokyo, JP

Establishment Address

19-10 SENJU, NAKAI-CHO,, ADACHI-KU Tokyo 120-0035, 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

K832621

PMA Number

N/A

All Registered Proprietary Names

TOP HYPODERMIC SYRINGE LUER LOCK NRFit Syringe TOP DISPOSABLE INFUSION SET SYRINGE TOP DISPOSABLE PLASTIC SYRINGES

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
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-03-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-03-02
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
3011500374	TOP CORPORATION OHMASU PLANT	ISHIOKA Ibaraki, JP
1000587249	MEDITOP CORPORATION (M) SDN BHD	BARU BANGI,SELANGOR DARUL EHSA, MY

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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18

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 9610993. Last updated year: 2026. Please use registration number 9610993 when referencing this establishment in official correspondence.