The following data is part of a premarket notification filed by Revmedx, Inc. with the FDA for Xstat-12, 3-pack, Xstat-12, 1-pack.
| Device ID | K161020 |
| 510k Number | K161020 |
| Device Name: | 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 | 2016-04-12 |
| Decision Date | 2016-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851587006042 | K161020 | 000 |