Guys, look at what I found.
I did a search on MEB’s approved 510K submission in 2018:
Date Received: 03/19/2018
Decision Date: 06/27/2018
It took 3 months and 1 week (about 100 days). So we should be able to receive the decision around the first week of August if not tomorrow.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180720
FDA Approval - before 29 July, page-267
-
- There are more pages in this discussion • 97 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
