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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lens, contact, polymethylmethacrylate, diagnostic
510(k) Number K142715
Device Name Sensor Medical Family of Vitrectomy Lenses and Products
Sensor Medical Technology, LLC
23175 224th Place SE
Maple Valley,  WA  98038
Applicant Contact Louise Culham
O’Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number886.1385
Classification Product Code
Date Received09/22/2014
Decision Date 12/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No