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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 K980554
Device Name ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING)
Applicant
ALDEN OPTICAL LABS., INC.
623 GLACIER DR.
GRAND JUNCTION,  CO  81503
Applicant Contact MARTIN J DALSING
Correspondent
ALDEN OPTICAL LABS., INC.
623 GLACIER DR.
GRAND JUNCTION,  CO  81503
Correspondent Contact MARTIN J DALSING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received02/13/1998
Decision Date 04/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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