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FDA 510(k) Application Details - K142914
Device Classification Name
Lacrimal Stents And Intubation Sets
More FDA Info for this Device
510(K) Number
K142914
Device Name
Lacrimal Stents And Intubation Sets
Applicant
ARMADILLO BIOMEDICAL, LLC
5363 Balbao Blvd., Suite 246
Encino, CA 91316 US
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Contact
Bruce Becker, M.D.
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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
10/07/2014
Decision Date
01/12/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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