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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K060453
Device Name AZE VIRTUALPLACE
Applicant
Aze, Ltd.
5353 Wayzata Blvd.
Suite 505
Minneapolis,  MN  55416 -1334
Applicant Contact CAROLE STAMP
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/22/2006
Decision Date 03/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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