Dissector,

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

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Available from:
Kalaparna Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
289955

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Public Summary

Summary for ARTG Entry:

289955

Kalaparna Pty Ltd - Dissector, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Kalaparna Pty Ltd

Postal Address

PO Box 3265,Dural, NSW, 2158

Australia

ARTG Start Date

8/06/2017

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

TeDan Surgical Innovations LLC

12615 W Airport Boulevard Suite 200

Sugarland, TX, 77478

United States Of America

Products

1. Dissector, <specify>

Product Type

Single Device Product

Effective date

8/06/2017

GMDN

44978 Dissector, <specify>

Intended purpose

Dissector to facilitate microdiscectomies, spinal decompression and lumbar fusion surgery.

Specific Conditions

No Specific Conditions included on Record

© 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 03.11.2017 at 05:30:56 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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