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FDA 510(k) Application Details - K042242
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K042242
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
ALDEN OPTICAL LABS., INC.
13295 BROADWAY
ALDEN, NY 14004 US
Other 510(k) Applications for this Company
Contact
CHARLES H CREIGHTON
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
08/19/2004
Decision Date
09/15/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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