Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616619

FEI Number

3001344828

Entity Name

DORMER LABORATORIES, INC.

City/State/Country

Toronto Ontario, CA

Establishment Address

91 KELFIELD ST., UNIT 5, Toronto Ontario M9W 5A3, CA

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DORMER LABORATORIES, (Owner Number: 9041255)

Owner / Operator Contact Address

91 KELFIELD ST., UNIT 5, --, Toronto, Ontario, CA-NOTA M9W 5A3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K992553

PMA Number

N/A

All Registered Proprietary Names

KXF / SYSTEM, DELIVERY, ALLERGEN AND VACCINE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2007-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

DORMER LABORATORIES,

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 9616619. Last updated year: 2026. Please use registration number 9616619 when referencing this establishment in official correspondence.