Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016739098

FEI Number

3016739098

Entity Name

SOUTH WEST EXPOSURES (2566031 ONT INC.)

City/State/Country

Toronto Ontario, CA

Establishment Address

523-50 Curzon Street, Toronto Ontario M4M 0C2, CA

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

South West Exposures (2566031 ONT Inc.) (Owner Number: 10070366)

Owner / Operator Contact Address

523-50 Curzon Street, Toronto, CA-ON M4M 0C2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SWE Vial Shield G10V SWE Vial Grip VG-001 SWE Vial Shield T10V SWE Vial Shield T30V SWE HiCap accessory SWE Vial Shield Y90V AcV20sf AcV20 50Vsf PbV25R SWE Vial shield G30V Pb20V AcV100 F18BULK50 TTS20 SWE Vial shield Y90S (SWE-EP1402-001) TVS30 EP1740 SWE Syringe Shield TS30 SWE Syringe Shield TS60 SWE Syringe Shield TS5 SWE Syringe Shield TSUD10 SWE Syringe Shield TSLu30 SWE Syringe Shield TSLu20 SWE Syringe Shield TS10 SWE Syringe Shield TSLu30W SWE Syringe Shield TPb20S SWE Syringe Shield R2_30W EP1796 SWE-EP1810-001 SWE Syringe Shield R2_20W EP1785 SWE Syringe Shield R2_20W EP1797 SWE Syringe Shield R2_20 EP1792

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWW	Shield, Vial	Radiology	Class 1	892.6500	2020-04-16
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-04-16

Official Correspondent

Robert Kamen

US Agent Details

Jenette Garbarz Business: Sirona Complete Care Email: jgarbarz@sironacc.com Phone: (330) 4234410

Related Public Records

Same Entity

South West Exposures (2566031 ONT 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 3016739098. Last updated year: 2026. Please use registration number 3016739098 when referencing this establishment in official correspondence.