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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Computer Controlled Surgical System
510(k) Number K140585
Device Name CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
Applicant
Curexo Technology Corporation
32 Harrison St.
Melrose,  MA  02176
Applicant Contact GLEN EMELOCK
Correspondent
Curexo Technology Corporation
32 Harrison St.
Melrose,  MA  02176
Correspondent Contact GLEN EMELOCK
Regulation Number882.4560
Classification Product Code
OJP  
Subsequent Product Code
HAW  
Date Received03/07/2014
Decision Date 08/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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