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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K150656
Device Name PRECICE Intramedullary Limb Lengthening System
Applicant
Ellipse Technologies, Incorporated
13900 Alton Parkway, Suite 123
Irvine,  CA  92618
Applicant Contact Rebecca Shelburne
Correspondent
Ellipse Technologies, Incorporated
13900 Alton Parkway, Suite 123
Irvine,  CA  92618
Correspondent Contact Rebecca Shelburne
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/13/2015
Decision Date 04/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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