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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K113732
Device Name IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
Applicant
Brainlab AG
Kapellenstrasse 12
Feldkirchen,  DE 85622
Applicant Contact ALEXANDER SCHWIERSCH
Correspondent
Brainlab AG
Kapellenstrasse 12
Feldkirchen,  DE 85622
Correspondent Contact ALEXANDER SCHWIERSCH
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
LLZ  
Date Received12/19/2011
Decision Date 05/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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