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FDA 510(k) Application Details - K111267
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K111267
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
ABBCONCISE OPTICAL GROUP, LLC
806 KIMBALL AVENUE
GRAND JUNCTION, CO 81501 US
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Contact
MARTIN DALSINGH
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
05/04/2011
Decision Date
11/08/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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