The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for Prevena Restor(tm) Incision Management System.
| Device ID | K181507 |
| 510k Number | K181507 |
| Device Name: | PREVENA RESTOR(TM) Incision Management System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249 |
| Contact | Kimberly Mccoy |
| Correspondent | Shannon Scott KCI USA, 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 | Yes |
| Date Received | 2018-06-07 |
| Decision Date | 2019-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554007116 | K181507 | 000 |
| 00849554007949 | K181507 | 000 |
| 00849554007130 | K181507 | 000 |
| 00849554007154 | K181507 | 000 |
| 00849554007178 | K181507 | 000 |
| 00849554007161 | K181507 | 000 |
| 00849554007123 | K181507 | 000 |
| 00849554007147 | K181507 | 000 |
| 00849554006805 | K181507 | 000 |
| 00849554007109 | K181507 | 000 |
| 00849554006812 | K181507 | 000 |
| 00849554007826 | K181507 | 000 |