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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spectacle, Magnifying
510(k) Number K931328
Device Name PYRAMID SUNGLASSES/PYRAMID READING GLASSES
Applicant
Pyramid
Box 6
La Grange,  TN  38046
Applicant Contact MARGARET COWAN
Correspondent
Pyramid
Box 6
La Grange,  TN  38046
Correspondent Contact MARGARET COWAN
Regulation Number886.5840
Classification Product Code
HOI  
Subsequent Product Code
HQY  
Date Received03/16/1993
Decision Date 08/10/1993
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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