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JAPAN 

   Alert   Text Revised   Attachment Revised      Title/Description    
   16-05   05/07/1998      11/14/2008
DET. W/O PHYS. EXAM OF MAHI MAHI DUE TO DECOMPOSITION AND HISTAMINES 
   53-14   05/23/1994      09/05/2006
INTENSIFIED COVERAGE OF TEMPORARY TATTOOS CONTAINING NON-PERMITTED COLOR ADDITIVES AND/OR FAILING TO BEAR INGREDIENT DEC 
   66-37   12/31/1997
OXYGEN UNITS 
   85-02   03/17/1998      09/03/2008
SURVEILLANCE (100% SAMPLING) AND DETENTION W/O PHYSICAL EXAMINATION OF CONDOMS 
   89-06   01/26/1988
AUTOMATIC DETENTION OF 'SUPER PULSE' ELECTRONIC DEVICES 
   89-08   08/13/2001      12/17/2008
DWPE OF CLASS III DEVICES W/O APPROVED PMA'S OR IDE'S AND OTHER DEVICES NOT EQUIVALENT OR NO 510K 
   95-03   09/28/1993
SURVEILLANCE OF IMPORTED LOW LEVEL LASER THERAPY (LLLT) DEVICES