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FDA 510(k) Application Details - K080794
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K080794
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
POLYVUE DISTRIBUTION, INC.
7077 MCADAMS LANE
FELTON, CA 95018 US
Other 510(k) Applications for this Company
Contact
GAROLD L EDWARDS
Other 510(k) Applications for this Contact
Regulation Number
886.5925
More FDA Info for this Regulation Number
Classification Product Code
LPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/20/2008
Decision Date
12/17/2008
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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