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Biotech / Medical : CYBR CyberCare the new look of healthcare -- Ignore unavailable to you. Want to Upgrade?


To: sommovigo who wrote (2052)6/1/2000 1:11:00 AM
From: Kevin Podsiadlik  Read Replies (1) | Respond to of 3392
 
That is weird... Either Herb has really good contacts at the FDA, or he's an awfully good guesser, or... could it be that the notification mentioned in the PR was not, as you assumed, the first such notice given to CYBR of the 200's general-purpose status?

For example, the notification might have been along the lines of: "You are hereby notified that you are forbidden from issuing any further press releases regarding the EHC 400 product, until such time as a determination of its approvability has been made. This sanction does not apply to the EHC 200, which, as you know, is classified as a general-purpose device and therefore not subject to FDA approval."

Last Friday's PR would be a technically accurate, if rather incomplete, reporting of such a notification.