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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K020006
Device Name DYNA INTRA-LIMBAL LENS
Applicant
Lens Dynamics, Inc.
8600 W. 14th Ave., #2
Lakewood,  CO  80215
Applicant Contact AL VASKE
Correspondent
Lens Dynamics, Inc.
8600 W. 14th Ave., #2
Lakewood,  CO  80215
Correspondent Contact AL VASKE
Regulation Number886.5916
Classification Product Code
HQD  
Date Received01/02/2002
Decision Date 03/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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