The following data is part of a premarket notification filed by Cardinal Health with the FDA for Kendall Npwt Incision Management Device.
| Device ID | K202217 |
| 510k Number | K202217 |
| Device Name: | Kendall NPWT Incision Management Device |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Cardinal Health 3651 Birchwood Drive Waukegan, IL 60085 |
| Contact | Christine Kuntz-nassif |
| Correspondent | Jillian Connery Patient Recovery, Cardinal Health 777 West Street Mansfield, MA 02048 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-06 |
| Decision Date | 2021-06-04 |