The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510.
| Device ID | K083357 |
| 510k Number | K083357 |
| Device Name: | OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| 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 | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-13 |
| Decision Date | 2009-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554001237 | K083357 | 000 |
| 00849554000247 | K083357 | 000 |