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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 K910597
Device Name SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2
Applicant
Radix Group Intl.
129 N. Hamilton Rd.
Columbus,  OH  43213
Applicant Contact JONNA BARR
Correspondent
Radix Group Intl.
129 N. Hamilton Rd.
Columbus,  OH  43213
Correspondent Contact JONNA BARR
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/12/1991
Decision Date 04/26/1991
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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