I Actually LIKE this News Even Though It Delays A
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Posted On: 05/22/2019 1:10:29 PM
Re: NOTsteve34 #1600
I Actually LIKE this News Even Though It Delays A Decision.
The Company will submit the new 510(k) application within the next few weeks. Due to heightened efficiency and new review guidelines at the FDA, the turnaround time on the 510(k) will be relatively short,” said Dr. Sree Koneru, Ph.D., VP of Product Development for BioElectronics.
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(Concerning RecoveryRX)
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As a side note, the Company is preparing to file its response to the FDA’s request for additional information on the postoperative pain 510(k) application, within the next week.
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About BioElectronics Corporation
That means we are 3-5 weeks out on a Decision for That Product Most Likely.
The Company will submit the new 510(k) application within the next few weeks. Due to heightened efficiency and new review guidelines at the FDA, the turnaround time on the 510(k) will be relatively short,” said Dr. Sree Koneru, Ph.D., VP of Product Development for BioElectronics.
--
(Concerning RecoveryRX)
--
As a side note, the Company is preparing to file its response to the FDA’s request for additional information on the postoperative pain 510(k) application, within the next week.
--
About BioElectronics Corporation
That means we are 3-5 weeks out on a Decision for That Product Most Likely.
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