FDA 510(k) Application Details - K023221

Device Classification Name	Lens, Contact, Polymethylmethacrylate, Diagnostic   More FDA Info for this Device
510(K) Number	K023221
Device Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
Applicant	VOLK OPTICAL, INC. 15825 SHADY GROVE RD. SUITE 30 ROCKVILLE, MD 20850 US Other 510(k) Applications for this Company
Contact	RICHARD E LIPPMAN 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	09/27/2002
Decision Date	10/11/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review