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FDA 510(k) Application Details - K984219
Device Classification Name
Lens,Prescription,Color Deficiency
More FDA Info for this Device
510(K) Number
K984219
Device Name
Lens,Prescription,Color Deficiency
Applicant
COLOR VISION TECHNOLOGIES, INC.
19726 COLIMA RD.
SUITE 320
ROWLAND HEIGHTS, CA 91748 US
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Contact
JULIE KIM
Other 510(k) Applications for this Contact
Regulation Number
886.5844
More FDA Info for this Regulation Number
Classification Product Code
NAI
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More FDA Info for this Product Code
Date Received
11/25/1998
Decision Date
11/18/1999
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
FDA Source Information for K984219
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