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Medical devices; reclassification and codification of natural nonabsorbable silk surgical suture--FDA. Final rule.

出版信息

Fed Regist. 1993 Oct 26;58(205):57557-8.

PMID:10129629
Abstract

The Food and Drug Administration (FDA) is announcing the reclassification and codification of natural nonabsorbable silk surgical suture. FDA issued an order in the form of a letter to the manufacturer reclassifying the device from class III (premarket approval) into class II (special controls). Accordingly, FDA is amending the regulations as set forth below.

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