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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 K863651
Device Name POLAREX AND POLAREX MLD
Applicant
Selex, Inc.
P. O. Box 48505
Doraville,  GA  30340
Applicant Contact FRED J DUNCAN
Correspondent
Selex, Inc.
P. O. Box 48505
Doraville,  GA  30340
Correspondent Contact FRED J DUNCAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/18/1986
Decision Date 10/10/1986
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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