Mr Google gave me an answer - should have gone there first!
Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.
Ann: AIR FDA 510K Filed and New US Distribution, page-3
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Mkt cap ! $5.136M | |||
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Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 486 | 2.1¢ |
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| Price($) | Vol. | No. |
|---|---|---|
| 2.8¢ | 12715 | 1 |
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