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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 3709
Contact david w payne
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/27/1994
Decision Date 09/06/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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