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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K102557
Device Name NOVAKONE SPHERICAL AND TORIC LENSES
Applicant
ALDEN OPTICAL LABS., INC.
13295 BROADWAY
ALDEN,  NY  14004
Applicant Contact CHARLES H CREIGHTON
Correspondent
ALDEN OPTICAL LABS., INC.
13295 BROADWAY
ALDEN,  NY  14004
Correspondent Contact CHARLES H CREIGHTON
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/07/2010
Decision Date 04/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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