The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Hemasorb Absorbable Bone Hemostat Matrix.
| Device ID | K111575 |
| 510k Number | K111575 |
| Device Name: | HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX |
| Classification | Wax, Bone |
| Applicant | ORTHOCON, INC. 1 Bridge St Ste 121 Irvington, NY 10533 |
| Contact | Rosemary Harry |
| Correspondent | Rosemary Harry ORTHOCON, INC. 1 Bridge St Ste 121 Irvington, NY 10533 |
| 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 | 2011-06-06 |
| Decision Date | 2012-05-23 |
| Summary: | summary |