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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 K935920
Device Name SPECTACLE FRAME
Applicant
Cadore Moda USA, Inc.
8011 NW 14th St.
Miami,  FL  33126
Applicant Contact RONALD KAPLAN
Correspondent
Cadore Moda USA, Inc.
8011 NW 14th St.
Miami,  FL  33126
Correspondent Contact RONALD KAPLAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/10/1993
Decision Date 02/25/1994
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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