The following data is part of a premarket notification filed by Kci Usa, Inc. (kinetic Concepts, Inc.) with the FDA for Abthera Open Abdomen Negative Pressure Therapy System.
| Device ID | K120499 |
| 510k Number | K120499 |
| Device Name: | ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. (KINETIC CONCEPTS, INC.) 6203 FARINON DRIVE San Antonio, TX 78249 |
| Contact | Margaret Marsh |
| Correspondent | Margaret Marsh KCI USA, INC. (KINETIC CONCEPTS, INC.) 6203 FARINON DRIVE San Antonio, TX 78249 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554006966 | K120499 | 000 |