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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aid, Vision, Electronic, Battery-Powered
510(k) Number K902187
Device Name POLARON
Applicant
Nurion Industries
Station Sq. Three
Paoli,  PA  19301
Applicant Contact WILLIAM P ROSEN
Correspondent
Nurion Industries
Station Sq. Three
Paoli,  PA  19301
Correspondent Contact WILLIAM P ROSEN
Regulation Number886.5900
Classification Product Code
HPG  
Date Received05/14/1990
Decision Date 08/08/1990
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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