FDA 510(k) Application Details - DEN180060

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180060
Device Name	Plenity
Applicant	Gelesis, Inc. 501 Boylston Street, Suite 6102 Boston, MA 02116 US Other 510(k) Applications for this Company
Contact	Eyal Ron Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2018
Decision Date	04/12/2019
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