The following data is part of a premarket notification filed by Revmedx, Inc. with the FDA for Xstat 30, 1-pack.
| Device ID | K180051 |
| 510k Number | K180051 |
| Device Name: | XSTAT 30, 1-Pack |
| Classification | Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use |
| Applicant | RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville, OR 97070 |
| Contact | Amy K. Pointer |
| Correspondent | Amy K. Pointer RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville, OR 97070 |
| Product Code | PGZ |
| CFR Regulation Number | 878.4452 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-08 |
| Decision Date | 2018-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851587006066 | K180051 | 000 |