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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 K083227
Device Name VIDA PULMONARY WORKSTATION 2 (PW2)
Applicant
Vida Diagnostics, Inc.
100 Oakdale Campus; Suite 225
Tic
Iowa City,  IA  52242
Applicant Contact JACK SLOVICK
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/03/2008
Decision Date 11/18/2008
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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