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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prism, Bar, Ophthalmic
510(k) Number K911374
Device Name PLASTIC OVERLAYS
Applicant
National Reading Service
2104 SW Adams St.
Peoria,  IL  61602
Applicant Contact SUMNER BORIN
Correspondent
National Reading Service
2104 SW Adams St.
Peoria,  IL  61602
Correspondent Contact SUMNER BORIN
Regulation Number886.1650
Classification Product Code
HKW  
Date Received03/28/1991
Decision Date 07/26/1991
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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