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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 K091327
Device Name ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
Applicant
Alden Optical Labs., Inc.
13295 Broadway
Alden,  NY  14004
Applicant Contact CHARLES CREIGHTON
Correspondent
Alden Optical Labs., Inc.
13295 Broadway
Alden,  NY  14004
Correspondent Contact CHARLES CREIGHTON
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/05/2009
Decision Date 06/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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