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Single-use device update

This article was originally published in The Gray Sheet

Executive Summary

FDA clears another dozen 510(k)s for third-party reprocessors. Alliance gets clearance for three 510(k)s, bringing its total to 15 out of 20 submitted. SterilMed gains another five, giving it 16 clearances out of 21 submitted. Lubbock, Texas-based third-party reprocessor Adven Medical obtains clearance for four 510(k)s. The firm has received agency sign-off on six out of 11 510(k)s. FDA agreed to extend the enforcement deadline for third-party reprocessors on Feb. 14 (1"The Gray Sheet" Feb. 18, 2002, p. 5)...
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