The following data is part of a premarket notification filed by Applied Tissue Technologies Llc with the FDA for Pwd Negative Pressure Wound Therapy System.
| Device ID | K212359 |
| 510k Number | K212359 |
| Device Name: | PWD Negative Pressure Wound Therapy System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Applied Tissue Technologies LLC 99 Derby St. Hingham, MA 02043 |
| Contact | Michael Broomhead |
| Correspondent | Michael Lucey Lakeshore Medical Device Consulting 128 Blye HIll Landing Newbury, NH 03255 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-29 |
| Decision Date | 2022-09-21 |