Mammosite Multi Lumen
FDA 510(k) K092405 · Hologic, Inc.
510(k) numberK092405
Submission
- Device name
- Mammosite Multi Lumen
- Applicant
- Hologic, Inc.
Marlborough, MA, US - Received
- August 6, 2009
- Decision date
- August 27, 2009
- Decision
- Unknown (SESU)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Mammosite Multi Lumen cleared by the FDA?
Mammosite Multi Lumen (K092405) received a 510(k) decision of Unknown on August 27, 2009, 21 days after the submission was received.
What is the product code of K092405?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.