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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 K113548
Device Name PEDCAT
Applicant
Curvebeam, LLC
175 Titus Ave.
Suite 300
Warrington,  PA  18976
Applicant Contact DAVID W COWAN
Correspondent
Curvebeam, LLC
175 Titus Ave.
Suite 300
Warrington,  PA  18976
Correspondent Contact DAVID W COWAN
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
OAS  
Date Received12/01/2011
Decision Date 04/10/2012
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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