Wednesday, February 23, 2011 6:14:49 PM
http://viewer.zoho.com/docs/d0dTh
Excerpt:
You may not Market this device until you provided adequaic information described above and required by 21 CFR 807.67 (J) and you have received a letter from the FDA allowing you to do so. If you market the device without conforming to these requirements you will be in violation of the Act.
KF
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