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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K932439
Device Name SPECTACLE FRAMES
Applicant
Styl-Rite Optics, Inc.
3350 NW 35th Ave.
P.O. Box 1380
Miami,  FL  33142
Applicant Contact THERESA JOHNSON
Correspondent
Styl-Rite Optics, Inc.
3350 NW 35th Ave.
P.O. Box 1380
Miami,  FL  33142
Correspondent Contact THERESA JOHNSON
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received05/19/1993
Decision Date 01/03/1994
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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