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FDA 510(k) Application Details - K140409
Device Classification Name
Cup, Eye
More FDA Info for this Device
510(K) Number
K140409
Device Name
Cup, Eye
Applicant
APOTHECARY PRODUCTS, INC.
11750 12TH AVE. SOUTH
BURNSVILLE, MN 55337 US
Other 510(k) Applications for this Company
Contact
JAMES JENKINS
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LXQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/18/2014
Decision Date
07/09/2014
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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