The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Abthera Open Abdomen Dressing, Model: M8275026.
| Device ID | K090489 |
| 510k Number | K090489 |
| Device Name: | ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | KCI USA, INC. 6203 FARINON DR. San Antonio, TX 78249 |
| Contact | Christy H Oviatt |
| Correspondent | Christy H Oviatt KCI USA, INC. 6203 FARINON DR. San Antonio, TX 78249 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554001268 | K090489 | 000 |