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Thursday, 02/22/2024 11:17:50 AM

Thursday, February 22, 2024 11:17:50 AM

Post# of 403369
Posted by plotdog:


plotdog
56m

https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232769.pdf

In the first paragraph on first page "You may, therefore, market the device, subject to the general controls
provisions of the Act". Leo reported in Aug that they were filing for submission in Q2. So we have approval already.

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