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Post# of 173103
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Friday, 12/29/2023 6:17:31 AM

Friday, December 29, 2023 6:17:31 AM

Post# of 173103
If this doesn't sound like all testing is complete and data analysis by the FDA completed then I don't know what more they would require

Dr. Mike Korenko stated “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions. The FDA did a very thorough review. The analysis in our Risk Management Report concluded that RadioGel™ is intrinsically safe and our animal therapy data verified its effectiveness

I'm thinking nothing

Breakthrough Devices Program.

Dr. Mike Korenko stated “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions
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