APPLIED TECHNOLOGY INTERNATIONAL, LTD DBA:FABRIFOAM PRODUCTS

FDA Device Registration & Listing · Exton, PA, US · Registration 3009491738

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
3009491738
FEI Number
3009491738
Entity Name
APPLIED TECHNOLOGY INTERNATIONAL, LTD DBA:FABRIFOAM PRODUCTS
City/State/Country
Exton, PA, US
Establishment Address
900 Springdale Dr, Exton, PA 19341, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Applied Technology International, LTD DBA:Fabrifoam Products (Owner Number: 10040146)
Owner / Operator Contact Address
900 Springdale Drive, Exton, PA 19341, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

IV Holder GuardION by Fabrifoam

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2024-05-07
FQM Bandage, Elastic General Hospital Class 1 880.5075 2012-11-16

Official Correspondent

Charlene Buckley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Applied Technology International, LTD DBA:Fabrifoam Products
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 3009491738. Last updated year: 2026. Please use registration number 3009491738 when referencing this establishment in official correspondence.
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