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  • Title: Medical devices; reclassification and codification of natural nonabsorbable silk surgical suture--FDA. Final rule.
    Journal: Fed Regist; 1993 Oct 26; 58(205):57557-8. PubMed ID: 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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