FDA 510(k) Application Details - K170183

Device Classification Name	Instrument, Vitreous Aspiration And Cutting, Ac-Powered   More FDA Info for this Device
510(K) Number	K170183
Device Name	Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant	A.R.C. Laser GmbH Bessemer St. 14 Nurnberg 90411 DE Other 510(k) Applications for this Company
Contact	Angela Thyzel 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	01/23/2017
Decision Date	09/27/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review