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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 K943039
Device Name SPECTACLE FRAMES
Applicant
Rodenstock USA Inc.,
P.O. Box 3709
Danbury,  CT  06813
Applicant Contact DAVID W PAYNE
Correspondent
Rodenstock USA Inc.,
P.O. Box 3709
Danbury,  CT  06813
Correspondent Contact DAVID W PAYNE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/27/1994
Decision Date 09/06/1994
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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