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FDA 510(k) Application Details - K053333
Device Classification Name
Plug, Punctum
More FDA Info for this Device
510(K) Number
K053333
Device Name
Plug, Punctum
Applicant
EAGLE VISION, INC.
8500 WOLF LAKE DR.
SUITE 110
MEMPHIS, TN 38133 US
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Contact
JEFF COBB
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LZU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2005
Decision Date
05/02/2006
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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