FDA 510(k) Application Details - K200073

Device Classification Name	Elastomer, Silicone Block   More FDA Info for this Device
510(K) Number	K200073
Device Name	Elastomer, Silicone Block
Applicant	Augmenta LLC 1315 St. Joesph Parkway, Suite 1700 Houston, TX 77002 US Other 510(k) Applications for this Company
Contact	Robert J Cornell Other 510(k) Applications for this Contact
Regulation Number	874.3620   More FDA Info for this Regulation Number
Classification Product Code	MIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2020
Decision Date	09/30/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review