FDA 510(k) Application Details - K223051

Device Classification Name	Elastomer, Silicone Block   More FDA Info for this Device
510(K) Number	K223051
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	Dr. 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	09/29/2022
Decision Date	02/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review