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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 K964316
Device Name PLASTIC SUNGLASSES
Applicant
Medical Reports Exchange, Inc.
2112 Cross Trails Rd.
Baltimore,  MD  21244
Applicant Contact E.J. Smith
Correspondent
Medical Reports Exchange, Inc.
2112 Cross Trails Rd.
Baltimore,  MD  21244
Correspondent Contact E.J. Smith
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/29/1996
Decision Date 12/17/1996
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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