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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 K931055
Device Name ITEM # 755 HOT SUNGLASSES
Applicant
South American Industrial Co.
C/O Sims, Waters & Assoc., Inc
444 Talleyrand Ave.
Jacksonville,  FL  32206
Applicant Contact TERRI KNOWLES
Correspondent
South American Industrial Co.
C/O Sims, Waters & Assoc., Inc
444 Talleyrand Ave.
Jacksonville,  FL  32206
Correspondent Contact TERRI KNOWLES
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/11/1993
Decision Date 10/01/1993
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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