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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Weights, Eyelid, External
510(k) Number K170591
Device Name Altomed Malhotra Platinum Segments
Applicant
Altomed Limited
2 Whitney Way
Bolden Business Park
Bolden, Tyne And Wear,  GB ne35 9pe
Applicant Contact Stuart March
Correspondent
Audrey Vitale, LLC
2 Witney Way
Tyne & Wear,  GB
Correspondent Contact Stuart March
Regulation Number886.5700
Classification Product Code
MML  
Date Received02/28/2017
Decision Date 06/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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