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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 K930198
Device Name LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
Applicant
Forda (China) Optical Co.
Wah Lok Indu. Cntr. 37-41 Shan
Mei St. Fo Tan Shatin
Hong Kong,  HK
Applicant Contact BLOCK B
Correspondent
Forda (China) Optical Co.
Wah Lok Indu. Cntr. 37-41 Shan
Mei St. Fo Tan Shatin
Hong Kong,  HK
Correspondent Contact BLOCK B
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/14/1993
Decision Date 08/23/1993
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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