FDA 510(k) Application Details - DEN150033

Device Classification Name	Oral Removable Retainer For Weight Loss   More FDA Info for this Device
510(K) Number	DEN150033
Device Name	Oral Removable Retainer For Weight Loss
Applicant	SCIENTIFIC INTAKE 2859 PACES FERRY ROAD SUITE 1710 ATLANTA, GA 30339 US Other 510(k) Applications for this Company
Contact	William Longley Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	ONY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2015
Decision Date	09/26/2016
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review