FDA 510(k) Application Details - K051103

Device Classification Name	Lens, Contact, Polymethylmethacrylate, Diagnostic   More FDA Info for this Device
510(K) Number	K051103
Device Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
Applicant	HAAG-STREIT USA, INC. 7361 CALHOUN PLACE, SUITE 500 ROCKVILLE, MD 20855-2765 US Other 510(k) Applications for this Company
Contact	EDUARDO MARCH Other 510(k) Applications for this Contact
Regulation Number	886.1385   More FDA Info for this Regulation Number
Classification Product Code	HJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2005
Decision Date	06/07/2005
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