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FDA 510(k), K103319, I-SEED
FDA 510(k), K103319, I-SEED
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510(K) Number: K103319
Device Name: I-SEED
Manufacturer: THERAGENICS CORP.
Device Classification Name: source, brachytherapy, radionuclide
Regulation Number: 892.5730
Classification Product Code: KXK
Date Received: 11/12/2010
Decision Date: 01/03/2011
Regulation Medical Specialty: Radiology
Device Name: I-SEED
Manufacturer: THERAGENICS CORP.
Device Classification Name: source, brachytherapy, radionuclide
Regulation Number: 892.5730
Classification Product Code: KXK
Date Received: 11/12/2010
Decision Date: 01/03/2011
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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