federal_register: 2014-22255

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-22255 Dental Devices; Reclassification of Salivary Stimulatory System, To Be Renamed Electrical Salivary Stimulator System Proposed Rule The Food and Drug Administration (FDA) is proposing to reclassify salivary stimulatory system, a class III device, into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes will provide a reasonable assurance of safety and effectiveness of the device. The Agency is proposing to rename the device "electrical salivary stimulatory system." 2014-09-18 2014 9 https://www.federalregister.gov/documents/2014/09/18/2014-22255/dental-devices-reclassification-of-salivary-stimulatory-system-to-be-renamed-electrical-salivary https://www.govinfo.gov/content/pkg/FR-2014-09-18/pdf/2014-22255.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to reclassify salivary stimulatory system, a class III device, into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the...

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