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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spectacle, Magnifying
510(k) Number K910329
Device Name SUNGLASSES
Applicant
Cutler & Gross Sloan Optical , Ltd.
16 Knightsbridge Green
London Sw1x 7ql
England,  GB
Applicant Contact GRAHAM CUTLER
Correspondent
Cutler & Gross Sloan Optical , Ltd.
16 Knightsbridge Green
London Sw1x 7ql
England,  GB
Correspondent Contact GRAHAM CUTLER
Regulation Number886.5840
Classification Product Code
HOI  
Date Received01/25/1991
Decision Date 03/12/1991
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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