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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 K854264
Device Name SUNGLASSES/OPTICAL FRAMES
Applicant
Wha Chun Industries, Co., Ltd.
190 Old Tappan Rd.
Tappan,  NY  10983
Applicant Contact INHO PARK
Correspondent
Wha Chun Industries, Co., Ltd.
190 Old Tappan Rd.
Tappan,  NY  10983
Correspondent Contact INHO PARK
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/23/1985
Decision Date 11/12/1985
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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