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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 K932646
Device Name ROLLENS POST-MYDRIATIC SUNGLASS
Applicant
Rollens Professional Products, Inc.
8651 E. Amherst Dr.
Unit A
Denver,  CO  80231
Applicant Contact DONALD WILLSON
Correspondent
Rollens Professional Products, Inc.
8651 E. Amherst Dr.
Unit A
Denver,  CO  80231
Correspondent Contact DONALD WILLSON
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/02/1993
Decision Date 09/20/1993
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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