ST&G Corporation Prosthetic Componentry - Prosthesis, external, leg, ankle/foot, component,

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Massons Healthcare
Class:
Class 1
Authorization status:
Included
Authorization number:
321869

Public Summary

Summary for ARTG Entry:

321869

Massons Healthcare - ST&G Corporation Prosthetic Componentry - Prosthesis, external, leg, ankle/foot,

component, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Massons Healthcare

Postal Address

Unit 15/111 Lewis Road,Knoxfield, VIC, 3180

Australia

ARTG Start Date

16/08/2019

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

ST&G Corporation

2691 Saturn Street

Brea, CA, 92821

United States Of America

Products

1. ST&G Corporation Prosthetic Componentry - Prosthesis, external, leg, ankle/foot, component, <specify>

Product Type

Medical device system

Effective date

16/08/2019

GMDN

41109 Prosthesis, external, leg, ankle/foot, component, <specify>

Intended purpose

Lower Limb Componentry and kits used in the Manufacture of External Prosthetic Limbs

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.11.2019 at 06:39:36 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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