federal_register: 2015-29638
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015-29638 | Dental Devices; Reclassification of Electrical Salivary Stimulator System | Rule | The Food and Drug Administration (FDA) is issuing a final order to reclassify the salivary stimulator system, a postamendments Class III device, into class II (special controls) and to rename the device the "electrical salivary stimulator system." The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. | 2015-11-20 | 2015 | 11 | https://www.federalregister.gov/documents/2015/11/20/2015-29638/dental-devices-reclassification-of-electrical-salivary-stimulator-system | https://www.govinfo.gov/content/pkg/FR-2015-11-20/pdf/2015-29638.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is issuing a final order to reclassify the salivary stimulator system, a postamendments Class III device, into class II (special controls) and to rename the device the "electrical salivary stimulator system." The... |