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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 K923746
Device Name MMELALENS SUNGLASSES
Applicant
Dwh, Inc.
P.O. Box 394
Boerne,  TX  78006
Applicant Contact DONALD W DUNLAP
Correspondent
Dwh, Inc.
P.O. Box 394
Boerne,  TX  78006
Correspondent Contact DONALD W DUNLAP
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/28/1992
Decision Date 06/21/1993
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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