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FDA 510(k) Application Details - K030054
Device Classification Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
More FDA Info for this Device
510(K) Number
K030054
Device Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Applicant
FCI OPHTHALMICS, INC.
344 ANNABELLE POINT RD.
CENTERVILLE, MA 02632-2402 US
Other 510(k) Applications for this Company
Contact
HILLARD WELCH
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
01/06/2003
Decision Date
02/26/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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