The following data is part of a premarket notification filed by Lifecell Corp. with the FDA for Lifecell Dural Substitute Matrix.
| Device ID | K061208 |
| 510k Number | K061208 |
| Device Name: | LIFECELL DURAL SUBSTITUTE MATRIX |
| Classification | Dura Substitute |
| Applicant | LIFECELL CORP. ONE MILLENIUM WAY Branchburg, NJ 08876 |
| Contact | Rey Librojo |
| Correspondent | Rey Librojo LIFECELL CORP. ONE MILLENIUM WAY Branchburg, NJ 08876 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-01 |
| Decision Date | 2007-01-03 |
| Summary: | summary |