The following data is part of a premarket notification filed by Anuncia Medical, Inc. with the FDA for Reflow System Mini.
| Device ID | K221918 |
| 510k Number | K221918 |
| Device Name: | ReFlow System Mini |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Anuncia Medical, Inc. 1355 N Scottsdale Rd, Suite 370 Scottsdale, AZ 85257 |
| Contact | Elsa Chi Abruzzo |
| Correspondent | Natalie Eagleburger Anuncia Medical, Inc. 1355 N Scottsdale Rd, Suite 370 Scottsdale, AZ 85257 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-01 |
| Decision Date | 2022-09-29 |