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Articles from Warning Letter Bulletin (May 17, 1999)

1-13 out of 13 article(s)
Title Author Type Words
ANIMAL DRUGS/FEED. 83
BLOOD & BIOLOGICS. 632
CDRH UNTITLED LETTERS. 1710
CDRH Web promo letters. 669
Cordis stent ad contradicts instructions in 510(k) clearance letter, FDA says. 152
Coronary artery claims may push 510(k) device to PMA status. 267
Don't mix 'CE mark' and U.S. approvals in promos, FDA tells Bausch & Lomb. 374
FOODS/DIETARY SUPPLEMENTS. 939
HUMAN DRUGS. 746
OXYGEN. 133
Pouncing on off-label Oratec Internet promo, FDA slaps references to news media. 908
Retracted language reappears in Emergency Filtration Products Web site. 165
Web page and brochure overstep 510(k) for orthodontic device, warning letter says. 186

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