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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 K904585
Device Name POST MYDRIATIC SPECTACLES
Applicant
Yorktowne Optical Co., Inc.
Industrial Park
P.O. Box 276
Emigsville,  PA  17318
Applicant Contact CHRISITINE F KNEPP
Correspondent
Yorktowne Optical Co., Inc.
Industrial Park
P.O. Box 276
Emigsville,  PA  17318
Correspondent Contact CHRISITINE F KNEPP
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/09/1990
Decision Date 10/26/1990
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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