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FDA 510(k) Application Details - K082393
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K082393
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
UNILENS CORP., USA
10431 72ND ST. NORTH
LARGO, FL 33777 US
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Contact
ALAN J FRAZER
Other 510(k) Applications for this Contact
Regulation Number
886.5925
More FDA Info for this Regulation Number
Classification Product Code
LPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/19/2008
Decision Date
09/11/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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