The following data is part of a premarket notification filed by Accuro Medical Products Llc with the FDA for Wound Pro Apex.
| Device ID | K100823 |
| 510k Number | K100823 |
| Device Name: | WOUND PRO APEX |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | ACCURO MEDICAL PRODUCTS LLC 3879 EAST 120TH AVE SUITE 328 Denver, CO 80233 |
| Contact | Todd Hubbard |
| Correspondent | Todd Hubbard ACCURO MEDICAL PRODUCTS LLC 3879 EAST 120TH AVE SUITE 328 Denver, CO 80233 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-24 |
| Decision Date | 2011-01-24 |
| Summary: | summary |