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FDA 510(k) Application Details - K130375
Device Classification Name
Lacrimal Stents And Intubation Sets
More FDA Info for this Device
510(K) Number
K130375
Device Name
Lacrimal Stents And Intubation Sets
Applicant
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
3308 JEFFERSON AVENUE
UPPER LEVEL
CINCINNATI, OH 45220 US
Other 510(k) Applications for this Company
Contact
BARBARA S FANT
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
02/14/2013
Decision Date
12/04/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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