The following data is part of a premarket notification filed by Stortford Medical Llc with the FDA for Mynewt Negative Pressure Wound Therapy System.
| Device ID | K161432 |
| 510k Number | K161432 |
| Device Name: | MyNeWT Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Stortford Medical LLC 295 Princeton Hightstown Road, Unit 321 West Windsor, NJ 08550 |
| Contact | Chris Daughtery |
| Correspondent | Chris Daughtery Stortford Medical LLC 295 Princeton Hightstown Road, Unit 321 West Windsor, NJ 08550 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-24 |
| Decision Date | 2017-02-08 |
| Summary: | summary |