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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 K960650
Device Name NON PRESCRIPTION SUN GLASSES
Applicant
SOLOVISION OPTICAL, INC.
2 N.E. 40TH ST.
2ND FLOOR
MIAMI,  FL  33137
Applicant Contact LINDA RAMOS
Correspondent
SOLOVISION OPTICAL, INC.
2 N.E. 40TH ST.
2ND FLOOR
MIAMI,  FL  33137
Correspondent Contact LINDA RAMOS
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/01/1996
Decision Date 03/19/1996
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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