The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Actifuse Flow.
| Device ID | K181306 |
| 510k Number | K181306 |
| Device Name: | Actifuse Flow |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Baxter Healthcare Corporation 32650 N Wilson Rd Round Lake, IL 60073 |
| Contact | Daniel Davis |
| Correspondent | Daniel Davis Baxter Healthcare Corporation 32650 N Wilson Rd Round Lake, IL 60073 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-17 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55060050780789 | K181306 | 000 |
| 55060050780772 | K181306 | 000 |
| 55060050780765 | K181306 | 000 |