The following data is part of a premarket notification filed by Kevo Medical Supplies with the FDA for Kevo Npwt-ahemo30 And A Hemo45 Foam Dressing Kit.
| Device ID | K113199 |
| 510k Number | K113199 |
| Device Name: | KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KEVO MEDICAL SUPPLIES 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith KEVO MEDICAL SUPPLIES 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-07-30 |
| Summary: | summary |