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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
Applicant
Sensor Medical Technology, LLC
23175 224th Pl. SE
Maple Valley,  WA  98038
Applicant Contact Louise Culham
Correspondent
O’Connell Regulatory Consultants, Inc.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number886.1385
Classification Product Code
HJK  
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
Predetermined Change
Control Plan Authorized		 No
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