Replies to post #79896 on Bioelectronics Corp (BIEL)

[MaxRain]

So things are going FW.. we can speculate what questions are but it doesnt matter.. fact is.. its moving forward.. doesnt say rejection.. doesnt say denial.. says.. we have answers to give on the 510k we are doing that and moving fw to July 20th meeting


Its happening

[cashpot]

I wonder if rockk was invited to attend the upcoming july 20th biel fda meeting? LMAO!

[Simpsonly]

Thanks to 7Up and G-Star - yup, sure does look as if the FDA has NOT rejected anything and that there is an ongoing process between BIEL (through its legal counsel) and the Lead Reviewer FDA) with all parties working forward on the 510(K) application for OTC Clearance for ActiPatch in the USA. It must be remembered that SWT and the reclassification to Class II from Class III is an FDA project! Tsunami building . . . . .