Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005288183

FEI Number

3005288183

Entity Name

TSK Laboratory International, Canada

City/State/Country

Vancouver British Columbia, CA

Establishment Address

1686 West 75th Avenue, Vancouver British Columbia V6P 6G2, CA

Establishment Type(s)

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

Owner / Operator

Johnson Global Medical Products Inc. (Owner Number: 10060825)

Owner / Operator Contact Address

1686 West 75th Avenue, Vancouver, CA-BC V6P 6G2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K970370

PMA Number

N/A

All Registered Proprietary Names

FOURTE Expander Fill System STERiGLIDE CSH Cannula STERiJECT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCJ	Tissue Expander And Accessories	Unknown	Class U	N/A	2021-12-03
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-07-05
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-07-02

Official Correspondent

Norman Johnson

US Agent Details

NORMAN JOHNSON Business: Johnson Global California Email: shane@tsklab.com Phone: (714) 7240294

Related Public Records

Same Entity

Johnson Global Medical Products Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161483	Stradis Healthcare	Unger Quad Injector	2016-10-31
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005288183. Last updated year: 2026. Please use registration number 3005288183 when referencing this establishment in official correspondence.