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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 K082159
Device Name CIVASTRING PD-103
Applicant
Civatech Oncology, Inc.
1317 Buchanan Dr.
Mebane,  NC  27302
Applicant Contact LOIS V SMART
Correspondent
Civatech Oncology, Inc.
1317 Buchanan Dr.
Mebane,  NC  27302
Correspondent Contact LOIS V SMART
Regulation Number892.5730
Classification Product Code
KXK  
Date Received07/31/2008
Decision Date 09/30/2008
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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