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To: Mr.Kups who wrote (6467)2/23/1999 10:07:00 PM
From: The Steve  Read Replies (1) | Respond to of 9824
 
Not sure about that. One of things that caused the delay in submission though is that Tilton said they wanted to get it right the first time. The FDA publishes guides that are pretty detailed in submitting devices. You can view them at the FDA site I believe. It isn't impossible that they just did it themselves, but there are firms out there that specialize in submitting devices like these to the FDA which they also could have used.

Steve