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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 K901047
Device Name SUNGLASSES
Applicant
Command Marketing Corp.
P.O. Box 551266
Dallas,  TX  75355
Applicant Contact JAMES LYNCH
Correspondent
Command Marketing Corp.
P.O. Box 551266
Dallas,  TX  75355
Correspondent Contact JAMES LYNCH
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/06/1990
Decision Date 05/15/1990
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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