The following data is part of a premarket notification filed by Osta Technologies with the FDA for Osta Maxigro And Regigro.
| Device ID | K091424 |
| 510k Number | K091424 |
| Device Name: | OSTA MAXIGRO AND REGIGRO |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | OSTA TECHNOLOGIES 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour OSTA TECHNOLOGIES 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-13 |
| Decision Date | 2010-08-18 |
| Summary: | summary |