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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K061051
Device Name DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
Applicant
SICEL TECHNOLOGIES, INC.
3800 GATEWAY CENTRE BLVD.
SUITE 308
MORRISVILLE,  NC  27560
Applicant Contact TAMMY B CARREA
Correspondent
SICEL TECHNOLOGIES, INC.
3800 GATEWAY CENTRE BLVD.
SUITE 308
MORRISVILLE,  NC  27560
Correspondent Contact TAMMY B CARREA
Regulation Number892.5050
Classification Product Code
LHN  
Subsequent Product Code
NZT  
Date Received04/17/2006
Decision Date 06/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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