The following data is part of a premarket notification filed by Lifenet with the FDA for Optium Dbm Gel And Putty.
| Device ID | K053098 |
| 510k Number | K053098 |
| Device Name: | OPTIUM DBM GEL AND PUTTY |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | LIFENET 5809 WARD CT. Virginia Beach, VA 23455 |
| Contact | David Klementowski |
| Correspondent | David Klementowski LIFENET 5809 WARD CT. Virginia Beach, VA 23455 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-03 |
| Decision Date | 2005-11-28 |
| Summary: | summary |