federal_register: 03-9869

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
03-9869 Medical Devices; Exemption From Premarket Notification; Class II Devices; Optical Impression Systems for Computer Assisted Design and Manufacturing Rule The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA). 2003-04-22 2003 4 https://www.federalregister.gov/documents/2003/04/22/03-9869/medical-devices-exemption-from-premarket-notification-class-ii-devices-optical-impression-systems https://www.govinfo.gov/content/pkg/FR-2003-04-22/pdf/03-9869.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket...

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