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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 K861927
Device Name CHILDREN'S SUNGLASSES
Applicant
Jestroy, Ltd.
Flat Q, 3rd Floor, Kaiser
Estate 3 Hok
Yuen St., Hunghom,  HK
Applicant Contact JAMES M GRAVES
Correspondent
Jestroy, Ltd.
Flat Q, 3rd Floor, Kaiser
Estate 3 Hok
Yuen St., Hunghom,  HK
Correspondent Contact JAMES M GRAVES
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/19/1986
Decision Date 06/17/1986
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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