Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005921952

FEI Number

3005921952

Entity Name

AUS SYSTEMS PTY LTD.

City/State/Country

ALLENBY GARDENS South Australia, AU

Establishment Address

3 CHARLES ST, ALLENBY GARDENS South Australia 5009, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AUS SYSTEMS PTY LTD. (Owner Number: 9076885)

Owner / Operator Contact Address

3 CHARLES ST, --, ALLENBY GARDENS, AU-SA 5009, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K062159

PMA Number

N/A

All Registered Proprietary Names

SPECIALTY SURGICAL PRODUCTS, INC. RB12 SUCTION RECTAL BIOPSY SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2019-05-27
FCK	Instrument, Biopsy, Suction	Gastroenterology, Urology	Class 2	876.1075	2006-09-12

Official Correspondent

PAUL ZADOW

US Agent Details

Dawn Nelson Business: SPECIALTY SURGICAL PRODUCTS INC Email: dnelson@ssp-inc.com Phone: (406) 9610102

Related Public Records

Same Entity

AUS SYSTEMS PTY LTD.

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 3005921952. Last updated year: 2026. Please use registration number 3005921952 when referencing this establishment in official correspondence.