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FDA 510(k) Application Details - K063617
Device Classification Name
Media, Corneal Storage
More FDA Info for this Device
510(K) Number
K063617
Device Name
Media, Corneal Storage
Applicant
AL.CHI.MI.A
377 ROUTE 17 S
HASBROUCK HEIGHTS, NJ 07604 US
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Contact
GEORGE MYERS
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LYX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2006
Decision Date
02/08/2007
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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