The following data is part of a premarket notification filed by Orthocon, Llc with the FDA for Hemasorb Resorbable Hemostatic Bone Putty.
| Device ID | K142339 |
| 510k Number | K142339 |
| Device Name: | HEMASORB Resorbable Hemostatic Bone Putty |
| Classification | Wax, Bone |
| Applicant | ORTHOCON, LLC 1 Bridge Street -Suite 121 Irvington, NY 10533 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer ORTHOCON, LLC 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 | 2014-08-21 |
| Decision Date | 2014-09-26 |
| Summary: | summary |