The following data is part of a premarket notification filed by Lifecell Corp. with the FDA for Ltm Wound Dressing.
| Device ID | K082103 |
| 510k Number | K082103 |
| Device Name: | LTM WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | LIFECELL CORP. ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Contact | Manal Morcos |
| Correspondent | Manal Morcos LIFECELL CORP. ONE MILLENNIUM WAY Branchburg, NJ 08876 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-25 |
| Decision Date | 2008-10-08 |
| Summary: | summary |