Tuesday, November 27, 2018 12:54:31 PM
Sree Koneru, VP of Product Development, expressed confidence in this strategy, both from a regulatory and marketability perspective. “We are also diligently proceeding with 510(k) applications for US market clearance of postoperative pain (RecoveryRx®) and menstrual pain (Allay®),” he added.
BIEL applied 2 510(K)s about the same time in JULY-AUG.
https://globenewswire.com/news-release/2018/11/27/1657557/0/en/BioElectronics-Announces-FDA-Market-Clearance-Update.html
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