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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 K922508
Device Name RUBBER FRAME SUNGLASSES
Applicant
Jedda Dist., Inc.
26 N. Rt. 9 W.
Congers,  NY  10920
Applicant Contact SY ROSENFELD
Correspondent
Jedda Dist., Inc.
26 N. Rt. 9 W.
Congers,  NY  10920
Correspondent Contact SY ROSENFELD
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/27/1992
Decision Date 08/26/1992
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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