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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 K970454
Device Name LAXIMA INTERNATIONAL LIMITED SUNGLASSES
Applicant
Laxima Intl., Ltd.
15-25 Chiu Lung St., 2nd Floor
Chiu Lung Bldg.
Central Hong Kong,  HK
Applicant Contact CHEN HAU CHEN
Correspondent
Laxima Intl., Ltd.
15-25 Chiu Lung St., 2nd Floor
Chiu Lung Bldg.
Central Hong Kong,  HK
Correspondent Contact CHEN HAU CHEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/05/1997
Decision Date 05/06/1997
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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