FDA 510(k) Application Details - K052674

Device Classification Name	Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)   More FDA Info for this Device
510(K) Number	K052674
Device Name	Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
Applicant	MEDITRON, GMBH 13605 W. 7TH AVE. GOLDEN, CO 80401-4604 US Other 510(k) Applications for this Company
Contact	ROBERT N CLARK Other 510(k) Applications for this Contact
Regulation Number	886.1385   More FDA Info for this Regulation Number
Classification Product Code	NYK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2005
Decision Date	05/24/2006
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