SIR-Spheres Microspheres Activity Calculator (SMAC)— 510(k) K202392
Substantially EquivalentSirtex Medical US Holdings, Inc.
FDA 510(k) clearance K202392 for SIR-Spheres Microspheres Activity Calculator (SMAC), Substantially Equivalent on 2020-10-23. Applicant: Sirtex Medical US Holdings, Inc.. Device class: 2.
Clearance details
- Applicant
- Sirtex Medical US Holdings, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woburn, MA, US
Recent devices under product code KPS
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