WESTONE LABORATORIES, INC.

FDA Device Registration & Listing · Colorado Springs, CO, US · Registration 2094377

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2094377
FEI Number
2094377
Entity Name
WESTONE LABORATORIES, INC.
City/State/Country
Colorado Springs, CO, US
Establishment Address
2260 Executive Cirle, Colorado Springs, CO 80906, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
WESTONE LABORATORIES, INC. (Owner Number: 9027818)
Owner / Operator Contact Address
2260 EXECUTIVE CIRCLE, Colorado Springs, CO 80906, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Impression Material Oto-Ease

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LDG Kit, Earmold, Impression Ear, Nose, Throat Class 1 874.3300 2017-11-27
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2019-01-31

Official Correspondent

Vanessa Webster

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WESTONE LABORATORIES, 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
K820587 Abco Dealers, Inc. WET PACK LINE OF PRODUCTS 1982-03-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2094377. Last updated year: 2026. Please use registration number 2094377 when referencing this establishment in official correspondence.
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