Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1065838

FEI Number

3003038113

Entity Name

AUGUSTA MEDICAL SYSTEMS, LLC

City/State/Country

AUGUSTA, GA, US

Establishment Address

1027 BROAD ST., AUGUSTA, GA 30901, US

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

AUGUSTA MEDICAL SYST (Owner Number: 9039218)

Owner / Operator Contact Address

1025 BROAD ST., P.O. BOX 10026, Augusta, GA 30901, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	Class 2	876.5020	2000-01-14

Official Correspondent

Michael Osbon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AUGUSTA MEDICAL SYST

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 1065838. Last updated year: 2026. Please use registration number 1065838 when referencing this establishment in official correspondence.