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FDA 510(k) Application Details - K041869
Device Classification Name
Lacrimal Stents And Intubation Sets
More FDA Info for this Device
510(K) Number
K041869
Device Name
Lacrimal Stents And Intubation Sets
Applicant
FCI OPHTHALMICS, INC.
P.O. BOX 465
76 PROSPECT ST.
MARSHFIELD HILLS, MA 02051 US
Other 510(k) Applications for this Company
Contact
LOUIS ARMAND
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
OKS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/09/2004
Decision Date
11/18/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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