Title 21: Food and Drugs
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/ PART 882 - NEUROLOGICAL DEVICES
/ Subpart F - Neurological Therapeutic Devices / § 882.5900 Preformed craniosynostosis strip.
§ 882.5900 Preformed craniosynostosis strip.
(a) Identification. A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.
(b) Classification. Class II (performance standards).