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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 K942932
Device Name GLADIATOR
Applicant
Gladiator Sports
3499 Cowes Mews
Dale City,  VA  22193
Applicant Contact MOHAMMAD AMJAD
Correspondent
Gladiator Sports
3499 Cowes Mews
Dale City,  VA  22193
Correspondent Contact MOHAMMAD AMJAD
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/22/1994
Decision Date 07/27/1994
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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