The following data is part of a premarket notification filed by 3-d Matrix, Inc. with the FDA for Purastat-om.
| Device ID | K210211 |
| 510k Number | K210211 |
| Device Name: | PuraStat-OM |
| Classification | Oral Wound Dressing |
| Applicant | 3-D Matrix, Inc. 1234 Chestnut St., Suite 205 Newton, MA 02464 |
| Contact | Lisa Spirio |
| Correspondent | Stephen P. Rhodes Streamline Regulatory 3502 Dundee Driveway Chevy Chase, MD 20815 |
| Product Code | OLR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-27 |
| Decision Date | 2021-10-08 |