Austin Medical, Inc.

FDA Device Registration & Listing · Waynesville, NC, US · Registration 3007139365

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
3007139365
FEI Number
3007139365
Entity Name
Austin Medical, Inc.
City/State/Country
Waynesville, NC, US
Establishment Address
190-A Industrial Park Drive, Waynesville, NC 28786, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Austin Medical, Inc. (Owner Number: 10023826)
Owner / Operator Contact Address
190-A Industrial Park Drive, Waynesville, NC 28786, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Kit, surgical instrument, disposable Fiber Medical, Absorbent Drape, Surgical, Exempt Support, Patient Position

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2023-08-31
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2022-08-29
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2017-08-02
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2012-03-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Austin Medical, 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 3007139365. Last updated year: 2026. Please use registration number 3007139365 when referencing this establishment in official correspondence.
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