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FDA 510(k) Application Details - K984436
Device Classification Name
Lens, Contact (Other Material) - Daily
More FDA Info for this Device
510(K) Number
K984436
Device Name
Lens, Contact (Other Material) - Daily
Applicant
PARAGON VISION SCIENCES
947 EAST IMPALA AVE.
MESA, AZ 85204 US
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Contact
WILLIAM E MEYERS
Other 510(k) Applications for this Contact
Regulation Number
886.5916
More FDA Info for this Regulation Number
Classification Product Code
HQD
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More FDA Info for this Product Code
Date Received
12/14/1998
Decision Date
04/21/1999
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
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