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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 K941555
Device Name SUNGLASSES/VARIOUS COLLECTIONS
Applicant
Atlantic Optical Co., Inc.
20801 Nordhoff St.
P.O. Box 3519
Chatsworth,  CA  91313
Applicant Contact MEL HOFFMAN
Correspondent
Atlantic Optical Co., Inc.
20801 Nordhoff St.
P.O. Box 3519
Chatsworth,  CA  91313
Correspondent Contact MEL HOFFMAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/31/1994
Decision Date 07/12/1994
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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