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FDA 510(k) Application Details - K112832
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K112832
Device Name
Case, Contact Lens
Applicant
EYE CARE AND CURE
4646 S OVERLAND DR
TUCSON, AZ 85714 US
Other 510(k) Applications for this Company
Contact
LINDY V DALEN
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2011
Decision Date
12/05/2011
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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