FDA 510(k) Application Details - K171165

Device Classification Name	Oral Removable Retainer For Weight Loss   More FDA Info for this Device
510(K) Number	K171165
Device Name	Oral Removable Retainer For Weight Loss
Applicant	Scientific Intake 280 Merrimack Street Suite 503 Lawrence, MA 01843 US Other 510(k) Applications for this Company
Contact	Marc Gibeley 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	04/20/2017
Decision Date	05/18/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review