The following data is part of a premarket notification filed by Sirtex Medical Us Holdings Inc. with the FDA for Sir-spheres Microspheres Activity Calculator (smac).
| Device ID | K202392 |
| 510k Number | K202392 |
| Device Name: | SIR-Spheres Microspheres Activity Calculator (SMAC) |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Sirtex Medical US Holdings Inc. 300 Unicorn Park, 2nd Fl. Woburn, MA 01801 |
| Contact | Michael P. Hanley |
| Correspondent | Michael P. Hanley Sirtex Medical US Holdings Inc. 300 Unicorn Park, 2nd Fl. Woburn, MA 01801 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2020-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850014612108 | K202392 | 000 |