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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 K932844
Device Name SUNGLASSES
Applicant
Glascal Industries, Ltd.
Tai Ping Indu. Centre, Blk 4
51a, Ting Kok Rd.
Tai Po,Nt, Hong Kong,  HK
Applicant Contact 8TH FL.
Correspondent
Glascal Industries, Ltd.
Tai Ping Indu. Centre, Blk 4
51a, Ting Kok Rd.
Tai Po,Nt, Hong Kong,  HK
Correspondent Contact 8TH FL.
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/10/1993
Decision Date 04/12/1994
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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