Summary for ARTG Entry:
Spectrum Surgical Pty Ltd - Keratome, line-powered
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, line-powered
Single Device Product
32765 Keratome, line-powered
An instrument that is electrically powered and intended to shave tissue from sections of the cornea for
No Specific Conditions included on Record
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Produced at 10.11.2017 at 03:20:23 AEDT
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