The following data is part of a premarket notification filed by Orthocon with the FDA for Hemasorb Resorbable Hemostatic Bone Putty.
| Device ID | K113627 |
| 510k Number | K113627 |
| Device Name: | HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY |
| Classification | Wax, Bone |
| Applicant | ORTHOCON 1 BRIDGE STREET SUITE 121 Irvington, NY 10533 |
| Contact | Rosemary Harry |
| Correspondent | Rosemary Harry ORTHOCON 1 BRIDGE STREET SUITE 121 Irvington, NY 10533 |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-08 |
| Decision Date | 2012-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850391007146 | K113627 | 000 |