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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 K934277
Device Name SUNGLASSES
Applicant
Rainbow Optics, Inc.
2 Norhteast 40th St.
Miami,  FL  33137 -3510
Applicant Contact PERRY POPKIN
Correspondent
Rainbow Optics, Inc.
2 Norhteast 40th St.
Miami,  FL  33137 -3510
Correspondent Contact PERRY POPKIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/31/1993
Decision Date 02/09/1994
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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