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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 K002845
Device Name PAFLUFOCON C AND E DAILY CONTACT LENS
Applicant
PARAGON VISION SCIENCES
947 EAST IMPALA AVE.
MESA,  AZ  85204
Applicant Contact WILLIAM E MEYERS
Correspondent
PARAGON VISION SCIENCES
947 EAST IMPALA AVE.
MESA,  AZ  85204
Correspondent Contact WILLIAM E MEYERS
Regulation Number886.5916
Classification Product Code
HQD  
Date Received09/12/2000
Decision Date 12/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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