7 ：名無し草 ：2005/07/27(水) 07:10:18
A device recently cleared under 510(k) is usually used as a predicate device. However, any legally U.S. marketed device may be used as a predicate.
A Premarket Notification [510(k)] is a premarketing submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA). Submitters must compare their 510(k) device to a similar legally marketed U.S. device(s). A device recently cleared under 510(k) is usually used as a predicate device. However, any legally U.S. marketed device may be used as a predicate. This includes: a device that has been cleared through the 510(k) process; a device that was legally marketed prior to May 28, 1976 (preamendments device); a device that was originally on the U.S. market as a Class III device (Premarket Approval) and later downclassified to Class II or I; or a 510(k) exempt device.
"Polarizer" means a permanently dichroic, polarizing glass article
having a sharp spectral cut-off at about 400 nm, and a precipitated
halide crystal phase that includes elongated metal halide crystallites
a portion of which crystallites near the surface of the glass article
are at least partially reduced to colloidal metal.
I'm halfway through this book. I'm assuming there's no Japanese version.
日本人はフロイトにそれほど関心ないはず。 http://www.amazon.com/gp/product/0671025716
The ASSAULT ON TRUTH: FREUD'S SUPPRESSION OF THE SEDUCTION THEORY (Paperback)
by Jeffrey Moussaieff Masson
