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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 K940277
Device Name PAFLUFOCON A, B, C & D
Applicant
PARAGON VISION SCIENCES
1100 EAST BELL RD.
PHOENIX,  AZ  85022
Applicant Contact DUANE TRACY
Correspondent
PARAGON VISION SCIENCES
1100 EAST BELL RD.
PHOENIX,  AZ  85022
Correspondent Contact DUANE TRACY
Regulation Number886.5916
Classification Product Code
HQD  
Date Received01/19/1994
Decision Date 05/09/1994
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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