The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Altapore Shape.
| Device ID | K191513 |
| 510k Number | K191513 |
| Device Name: | Altapore Shape |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-07 |
| Decision Date | 2019-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085412654393 | K191513 | 000 |
| 00085412654386 | K191513 | 000 |
| 00085412654379 | K191513 | 000 |
| 00085412654362 | K191513 | 000 |