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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 K925428
Device Name SUNGLASSES
Applicant
DALLAS HANDBAG CO.
12222 NORTH CENTRAL EXPRESSWAY
DALLAS,  TX  75243
Applicant Contact MIKE MANNING
Correspondent
DALLAS HANDBAG CO.
12222 NORTH CENTRAL EXPRESSWAY
DALLAS,  TX  75243
Correspondent Contact MIKE MANNING
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/27/1992
Decision Date 09/20/1993
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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