FDA 510(k) Application Details - K153168

Device Classification Name	Instrument, Vitreous Aspiration And Cutting, Ac-Powered   More FDA Info for this Device
510(K) Number	K153168
Device Name	Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant	MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES 557 MCCORMICK STREET SAN LEANDRO, CA 94577 US Other 510(k) Applications for this Company
Contact	Brenda Balletto Other 510(k) Applications for this Contact
Regulation Number	886.4150   More FDA Info for this Regulation Number
Classification Product Code	HQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2015
Decision Date	04/29/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review