The following data is part of a premarket notification filed by Lifecell Corp. with the FDA for Lifecell Tissue Expander.
| Device ID | K112534 |
| 510k Number | K112534 |
| Device Name: | LIFECELL TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | LIFECELL CORP. ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Contact | Kristen Meany |
| Correspondent | Kristen Meany LIFECELL CORP. ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-01 |
| Decision Date | 2012-08-10 |
| Summary: | summary |