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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 K942375
Device Name SUNGLASSES
Applicant
Kool World, Inc.
1350 Broadway Rm. 1610
New York,  NY  10018
Applicant Contact EMILY LAM
Correspondent
Kool World, Inc.
1350 Broadway Rm. 1610
New York,  NY  10018
Correspondent Contact EMILY LAM
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/18/1994
Decision Date 06/03/1994
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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