FDAnews Device Daily Bulletin

OSTEOTECH GRAFTON DBM FAMILY OF PRODUCTS RECEIVES FDA 510(K) CLEARANCE EXTENSION

Nov. 15, 2005
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Osteotech recently announced that it has been informed by the Food and Drug Administration ("FDA") that FDA is granting Osteotech an extension to clear its previously filed Grafton DBM 510(k) applications until such time as the Agency is able to complete its work on the applications. Specifically, the FDA said it has decided to continue its enforcement discretion for all 510(k) applications that are under review prior to the original deadline of November 15.

PR Newswire (http://www.prnewswire.com/news/index_mail.shtml?ACCT=104&STORY=/www/story/11-11-2005/0004214071&EDATE=)