The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Orthocon Hemasorb Resorbable Hemostatic Bone Putty.
| Device ID | K063330 |
| 510k Number | K063330 |
| Device Name: | ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY |
| Classification | Wax, Bone |
| Applicant | ORTHOCON, INC. 167 STONE HILL RD. Colts Neck, NJ 07722 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer ORTHOCON, INC. 167 STONE HILL RD. Colts Neck, NJ 07722 |
| 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 | 2006-11-03 |
| Decision Date | 2006-11-22 |
| Summary: | summary |