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FDA 510(k) Application Details - K050623
Device Classification Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
More FDA Info for this Device
510(K) Number
K050623
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
03/10/2005
Decision Date
03/28/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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