GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005— 510(k) K003206
Substantially EquivalentProxima Therapeutics, Inc.
FDA 510(k) clearance K003206 for GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005, Substantially Equivalent on 2001-04-25. Applicant: Proxima Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Proxima Therapeutics, Inc.
- Product code
- Code KXK
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code KXK
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Data sourced from openFDA. This site is unofficial and independent of the FDA.