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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 K932484
Device Name MARS SUNGLASSES
Applicant
Mars Promotional Services, Inc.
15770 N. Dallas Pkwy.,
Suite 420
Dallas,  TX  75248
Applicant Contact DEBRA MARS-MARSHALL
Correspondent
Mars Promotional Services, Inc.
15770 N. Dallas Pkwy.,
Suite 420
Dallas,  TX  75248
Correspondent Contact DEBRA MARS-MARSHALL
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/24/1993
Decision Date 07/25/1994
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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