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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
510(k) Number K944700
Device Name ARCTIC PREMIER SERIES
Applicant
SUNGOLD EYEWEAR, INC.
5866 S. 194TH ST.
KENT,  WA  98032
Applicant Contact MICHAEL B JOHNSON
Correspondent
SUNGOLD EYEWEAR, INC.
5866 S. 194TH ST.
KENT,  WA  98032
Correspondent Contact MICHAEL B JOHNSON
Regulation Number886.4750
Classification Product Code
HOY  
Date Received09/23/1994
Decision Date 12/22/1994
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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