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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Electric
510(k) Number K132264
Device Name PRIMADO2 TOTAL SURGICAL SYSTEM
Applicant
Nakanishi, Inc.
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Applicant Contact DIANE RUTHERFORD
Correspondent
Nakanishi, Inc.
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number882.4360
Classification Product Code
HBC  
Subsequent Product Codes
ERL   HBE   HWE  
Date Received07/22/2013
Decision Date 12/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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