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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dosimeter, Ionizing Radiation, Implanted
510(k) Number K083035
Device Name DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
Applicant
Sicel Technologies, Inc.
3800 Gateway Centre Blvd.
Suite 308
Morrisville,  NC  27560
Applicant Contact SUZANNE SCHWALLER
Correspondent
Sicel Technologies, Inc.
3800 Gateway Centre Blvd.
Suite 308
Morrisville,  NC  27560
Correspondent Contact SUZANNE SCHWALLER
Regulation Number892.5050
Classification Product Code
NZT  
Date Received10/14/2008
Decision Date 11/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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