The following data is part of a premarket notification filed by Cardinal Health with the FDA for Cardinal Health Npwt Pro, Cardinal Health Npwt Pro To Go, Cardinal Health Npwt Pro At Home.
| Device ID | K143016 |
| 510k Number | K143016 |
| Device Name: | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO To Go, Cardinal Health NPWT PRO At Home |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | CARDINAL HEALTH 1500 S Waukegan Rd Waukegan, IL 60085 |
| Contact | Tatyana Bogdan |
| Correspondent | Allison Scott NAVIGANT CONSULTING, INC. 9001 WESLEYAN ROAD, SUITE 200 Indianapolis, IN 46268 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-20 |
| Decision Date | 2015-04-20 |
| Summary: | summary |