Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss. Final order.
Fed Regist
; 82(144): 35067-9, 2017 Jul 28.
Article
en En
| MEDLINE
| ID: mdl-28753260
The Food and Drug Administration (FDA or Agency) is classifying the oral removable palatal space occupying device for weight management and/or weight loss into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the oral removable palatal space occupying device for weight management and/or weight loss classification. 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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Seguridad de Equipos
/
Gastroenterología
Límite:
Humans
Idioma:
En
Revista:
Fed Regist
Año:
2017
Tipo del documento:
Article
Pais de publicación:
Estados Unidos