federal_register: 2011-2552

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-2552 Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System for Aesthetic Use Rule The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device type. 2011-02-07 2011 2 https://www.federalregister.gov/documents/2011/02/07/2011-2552/medical-devices-general-and-plastic-surgery-devices-classification-of-contact-cooling-system-for https://www.govinfo.gov/content/pkg/FR-2011-02-07/pdf/2011-2552.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA...

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