The following data is part of a premarket notification filed by Cardinal Health with the FDA for Kendall Npwt Incision Management Dressing Kit.
| Device ID | K191101 |
| 510k Number | K191101 |
| Device Name: | Kendall NPWT Incision Management Dressing Kit |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Cardinal Health 3651 Birchwood Drive Waukegan, IL 60085 |
| Contact | Christine Nuntz-nassif |
| Correspondent | Christine Kuntz-nassif Cardinal Health 3651 Birchwood Drive Waukegan, IL 60085 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-25 |
| Decision Date | 2020-07-31 |