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FDA 510(k) Application Details - K954548
Device Classification Name
Media, Corneal Storage
More FDA Info for this Device
510(K) Number
K954548
Device Name
Media, Corneal Storage
Applicant
CHEN OPHTHALMIC LABORATORIES
13704 KILLARNEY COURT
PHOENIX, MD 21131 US
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Contact
CHUNG-HO CHEN
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
10/02/1995
Decision Date
05/20/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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