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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 K946231
Device Name EYE COOLER
Applicant
Direct Import Marketing Co.
1118 Appleton
Mansfield,  TX  76063
Applicant Contact WORDY THOMPSON
Correspondent
Direct Import Marketing Co.
1118 Appleton
Mansfield,  TX  76063
Correspondent Contact WORDY THOMPSON
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/22/1994
Decision Date 01/17/1995
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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