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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 K925803
Device Name A.J. MORGAN SUNGLASSES
Applicant
A.J. Morgan Ent.
P.O. Box 79215
Los Angeles,  CA  90079
Applicant Contact JANET MORGAN
Correspondent
A.J. Morgan Ent.
P.O. Box 79215
Los Angeles,  CA  90079
Correspondent Contact JANET MORGAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/16/1992
Decision Date 07/29/1993
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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