Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009168983

FEI Number

3009168983

Entity Name

CALDERA INTERNATIONAL, INC.

City/State/Country

Canby, OR, US

Establishment Address

294 NW 2nd Ave., Canby, OR 97013, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Caldera International, Inc. (Owner Number: 10037632)

Owner / Operator Contact Address

294 NW 2nd Ave., Canby, OR 97013, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Caldera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2011-08-02

Official Correspondent

Daniel Godfrey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Caldera International, 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 3009168983. Last updated year: 2026. Please use registration number 3009168983 when referencing this establishment in official correspondence.