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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 K063177
Device Name RAPID STRAND RX
Applicant
ONCURA INC.
43 PALMETTO WAY
NORTH BRUNSWICK,  NJ  08902
Applicant Contact SUBHASH PATEL
Correspondent
ONCURA INC.
43 PALMETTO WAY
NORTH BRUNSWICK,  NJ  08902
Correspondent Contact SUBHASH PATEL
Regulation Number892.5730
Classification Product Code
KXK  
Date Received10/19/2006
Decision Date 11/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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