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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 K912509
Device Name MOSSIMO OPTIC EYEWEAR
Applicant
Mossimo, Inc.
3 Goodyear
Irvine,  CA  92718
Applicant Contact LISA ARNETT
Correspondent
Mossimo, Inc.
3 Goodyear
Irvine,  CA  92718
Correspondent Contact LISA ARNETT
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/06/1991
Decision Date 01/06/1992
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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