Hi,
We are in the process of 510k submission (traditional). Review and Clearance timelines would be a challenge , as are targeting a launch in 3 months. Does any one have any recent experience with third party review and a third party reviewer that you can recommend? ( Device -ophthalmic laser , code -HQF)
Thanks & Regards,
|  | Rashmi Pillay Regulatory Affairs Manager Ellex – Lumibird Medical group 3-4 Second Avenue, Mawson lakes SA 5095 Tel. +61 8 7074 8105 Email :rpillay@ellex.com |
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