The following data is part of a premarket notification filed by Lifecell Corp. with the FDA for Allocraft Dbm.
| Device ID | K052735 |
| 510k Number | K052735 |
| Device Name: | ALLOCRAFT DBM |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | LIFECELL CORP. 555 13TH STREET, NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein LIFECELL CORP. 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-12-28 |
| Summary: | summary |