Summary for ARTG Entry:
Spectrum Surgical Pty Ltd - Keratome blade, single-use
ARTG entry for
Medical Device Included Class IIa
Spectrum Surgical Pty Ltd
Suite 44 Building 4 / 195 Wellington Road,CLAYTON, VIC, 3168
ARTG Start Date
Medical Device Class IIa
- 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.
Suite 102 / 26061 Merit Circle
Laguna Hills, CA, 92653
United States Of America
1. Keratome blade, single-use
Single Device Product
44722 Keratome blade, single-use
A single use thin blade mounted in a keratome to shave tissue from sections of the corneal lamellar.
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.
Page 1 of
Produced at 10.11.2017 at 03:20:07 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