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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 K944312
Device Name SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR
Applicant
Shelin International Ent., Inc.
523 Durant Ave.
San Leandro,  CA  94577
Applicant Contact REGULATORY AFFAIRS PERSON
Correspondent
Shelin International Ent., Inc.
523 Durant Ave.
San Leandro,  CA  94577
Correspondent Contact REGULATORY AFFAIRS PERSON
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received09/02/1994
Decision Date 11/22/1994
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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