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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 K904197
Device Name CHILDRENS SUNGLASSES
Applicant
Jasco Products Co., Inc.
P.O. Box 466
Oklahoma City,  OK  73101
Applicant Contact HAROLD PLUNK
Correspondent
Jasco Products Co., Inc.
P.O. Box 466
Oklahoma City,  OK  73101
Correspondent Contact HAROLD PLUNK
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/12/1990
Decision Date 11/05/1990
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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