FDA 510(k) Application Details - K050856

Device Classification Name	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)   More FDA Info for this Device
510(K) Number	K050856
Device Name	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Applicant	OPHTHOCARE LTD. 11 MENACHEM BEGIN ST. RAMAT-GAN 52521 IL Other 510(k) Applications for this Company
Contact	DORIT WINITZ 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	04/05/2005
Decision Date	05/31/2005
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