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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 K883771
Device Name SUNGLASSES, IMPORTED
Applicant
Norcon, Inc.
15960 Muirfield Ct.
Ft. Myers,  FL  33908
Applicant Contact G MILLEY
Correspondent
Norcon, Inc.
15960 Muirfield Ct.
Ft. Myers,  FL  33908
Correspondent Contact G MILLEY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/06/1988
Decision Date 09/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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