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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 WEST 14TH AVE., #2
LAKEWOOD,  CO  80215
Applicant Contact AL VASKE
Correspondent
LENS DYNAMICS, INC.
8600 WEST 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
Recalls CDRH Recalls
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