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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 K052983
Device Name FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES
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 Received10/24/2005
Decision Date 02/10/2006
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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