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FDA 510(k) Application Details - K033594
Device Classification Name
Lens, Contact (Other Material) - Daily
More FDA Info for this Device
510(K) Number
K033594
Device Name
Lens, Contact (Other Material) - Daily
Applicant
CONTAMAC LTD.
623 GLACIER DR.
GRAND JUNCTION, CO 81503 US
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Contact
MARTIN DALSING
Other 510(k) Applications for this Contact
Regulation Number
886.5916
More FDA Info for this Regulation Number
Classification Product Code
HQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/13/2003
Decision Date
03/19/2004
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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