FDA 510(k) Application Details - K132042

Device Classification Name	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)   More FDA Info for this Device
510(K) Number	K132042
Device Name	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Applicant	X6D, LTD. 21 HANAFA STREET ZUR- MOSHE 42810 IL Other 510(k) Applications for this Company
Contact	KAREL VAN GORP Other 510(k) Applications for this Contact
Regulation Number	886.4750   More FDA Info for this Regulation Number
Classification Product Code	HOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2013
Decision Date	04/28/2014
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