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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 K901945
Device Name SUNGLASSES - IMPACT RESISTANT LENSES (ACRYLIC)
Applicant
Zebco Corp.
Post Office Box 270
Tulsa,  OK  74101
Applicant Contact ROBERT A TERRY
Correspondent
Zebco Corp.
Post Office Box 270
Tulsa,  OK  74101
Correspondent Contact ROBERT A TERRY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/30/1990
Decision Date 07/05/1990
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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