The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Kci Npwt Gauze Dressing.
| Device ID | K123507 |
| 510k Number | K123507 |
| Device Name: | KCI NPWT GAUZE DRESSING |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. 6203 FARINON DR. San Antonio, TX 78249 |
| Contact | Anona Goebel |
| Correspondent | Anona Goebel 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 | Yes |
| Date Received | 2012-11-13 |
| Decision Date | 2013-04-04 |
| Summary: | summary |