The following data is part of a premarket notification filed by Revmedx, Inc. with the FDA for Xstat 30, 3-pack; Xstat 30, 1-pack; Xstat 12, 3 Pack; Xstat 12, 1 Pack.
| Device ID | K170334 |
| 510k Number | K170334 |
| Device Name: | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 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 | 2017-02-02 |
| Decision Date | 2017-05-01 |
| Summary: | summary |