The following data is part of a premarket notification filed by Resorbable Orthopedic Products, Llc with the FDA for Rop Resorbable Hemostasis Material.
| Device ID | K153095 |
| 510k Number | K153095 |
| Device Name: | ROP Resorbable Hemostasis Material |
| Classification | Wax, Bone |
| Applicant | Resorbable Orthopedic Products, LLC 16633 Dallas Parkway, Suite 250 Addison, TX 75001 |
| Contact | Barry E Constantine |
| Correspondent | Patsy J Trisler Trisler Consulting 5600 Wisconsin Ave Chevy Chase, MD 20815 |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-26 |
| Decision Date | 2016-02-17 |
| Summary: | summary |