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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 K160325
Device Name PRECICE Intramedullary Limb Lengthening System
Applicant
ELLIPSE TECHNOLOGIES, INC.
101 ENTERPRISE, SUITE 100
Aliso Viejo,  CA  92656
Applicant Contact Cora Sim
Correspondent
ELLIPSE TECHNOLOGIES, INC.
101 ENTERPRISE, SUITE 100
Aliso Viejo,  CA  92656
Correspondent Contact Cora Sim
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/05/2016
Decision Date 04/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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