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![]()
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FDA Approval - before 29 July, page-267
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