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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sunglasses (non-prescription including photosensitive)
510(k) Number K882813
Device Name NEOLENS SUNGLASSES
Applicant
NEOLENS, INC.
18963 N.E. 4TH CT.
MIAMI,  FL  33179
Applicant Contact CLAYMAN, MD
Correspondent
NEOLENS, INC.
18963 N.E. 4TH CT.
MIAMI,  FL  33179
Correspondent Contact CLAYMAN, MD
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/08/1988
Decision Date 07/29/1988
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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