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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name source, brachytherapy, radionuclide
510(k) Number K122764
Device Name RAPID STRAND RX
Applicant
MEDI-PHYSICS, INC.
3350 NORTH RIDGE AVE.
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact DAVID RISLEY
Correspondent
MEDI-PHYSICS, INC.
3350 NORTH RIDGE AVE.
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact DAVID RISLEY
Regulation Number892.5730
Classification Product Code
KXK  
Date Received09/10/2012
Decision Date 12/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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