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FDA 510(k) Application Details - K063304
Device Classification Name
Media, Corneal Storage
More FDA Info for this Device
510(K) Number
K063304
Device Name
Media, Corneal Storage
Applicant
NUMEDIS, INC.
188 BUMSTEAD RD.
MONSON, MA 01057 US
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Contact
MARY E FREDDO
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LYX
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More FDA Info for this Product Code
Date Received
11/01/2006
Decision Date
12/21/2007
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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