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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
Predetermined Change
Control Plan Authorized		 No
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