The following data is part of a premarket notification filed by Integrated Healing Technologies with the FDA for Newera Small Dome Kit, Newera Medium Dome Kit, Newera Large Dome Kit.
| Device ID | K142956 |
| 510k Number | K142956 |
| Device Name: | NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Integrated Healing Technologies 103 Forrest Crossing Blvd, Suite 103 Franklin, TN 37064 |
| Contact | Ian Baird |
| Correspondent | Ian Baird Integrated Healing Technologies 103 Forrest Crossing Blvd, Suite 103 Franklin, TN 37064 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-14 |
| Decision Date | 2015-02-24 |
| Summary: | summary |