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510(k) K140490

CIVA SHEET PD-103 by Civatech Oncology, Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2014
Date Received
February 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Civatech Oncology, Inc.

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  • K190839 — GammaTile (January 23, 2020)
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  • K180515 — GammaTile (July 6, 2018)