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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 K944160
Device Name SILHOUETTE, SUNLIMETED,ADIDAS
Applicant
Silhouette Optical , Ltd.
266 Union St.
Northvale,  NJ  07647
Applicant Contact W HUBER
Correspondent
Silhouette Optical , Ltd.
266 Union St.
Northvale,  NJ  07647
Correspondent Contact W HUBER
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/26/1994
Decision Date 09/28/1994
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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