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FDA 510(k) Application Details - K053191
Device Classification Name
Lens, Contact, (Disposable)
More FDA Info for this Device
510(K) Number
K053191
Device Name
Lens, Contact, (Disposable)
Applicant
INNOVA VISION INC.
2904 N. BOLDT DRIVE
FLAGGSTAFF, AZ 86001 US
Other 510(k) Applications for this Company
Contact
JENNIFER REICH
Other 510(k) Applications for this Contact
Regulation Number
886.5925
More FDA Info for this Regulation Number
Classification Product Code
MVN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/15/2005
Decision Date
05/12/2006
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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