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FDA 510(k) Application Details - K974636
Device Classification Name
Lens, Contact (Other Material) - Daily
More FDA Info for this Device
510(K) Number
K974636
Device Name
Lens, Contact (Other Material) - Daily
Applicant
FUTURISTIC DESIGN ASSOC.
ONE AVALON RD.
P.O. BOX 1009
MOUNT VERNON, OH 43050 US
Other 510(k) Applications for this Company
Contact
WILLIAM PLATT
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
12/12/1997
Decision Date
03/30/1998
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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