The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Altapore Mis.
| Device ID | K201464 |
| 510k Number | K201464 |
| Device Name: | Altapore MIS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
| Contact | Phillip Romei |
| Correspondent | Phillip Romei Baxter Healthcare Corporation 32650 N. Wilson Road 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 | 2020-06-02 |
| Decision Date | 2020-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085412678146 | K201464 | 000 |
| 00085412630731 | K201464 | 000 |