The following data is part of a premarket notification filed by Cardinal Health with the FDA for Cardinal Health Npwt Pro Hc.
| Device ID | K150124 |
| 510k Number | K150124 |
| Device Name: | Cardinal Health NPWT PRO HC |
| 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 | 2015-01-20 |
| Decision Date | 2015-09-02 |
| Summary: | summary |