FDA 510(k) Application Details - K181387

Device Classification Name	Elastomer, Silicone Block   More FDA Info for this Device
510(K) Number	K181387
Device Name	Elastomer, Silicone Block
Applicant	International Medical Devices, Inc. 717 North Maple Drive Beverly Hills, CA 90210 US Other 510(k) Applications for this Company
Contact	James Elist 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	05/25/2018
Decision Date	01/23/2019
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