The following data is part of a premarket notification filed by Applied Tissue Technologies Llc with the FDA for Pwd Platform Wound Dressing 3” X 5” Oblong.
| Device ID | K191460 |
| 510k Number | K191460 |
| Device Name: | PWD Platform Wound Dressing 3” X 5” Oblong |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Applied Tissue Technologies LLC 99 Derby St., Suite 700 Hingham, MA 02043 |
| Contact | Michael Broomhead |
| Correspondent | Michele Lucey Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, NH 03255 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-03 |
| Decision Date | 2019-07-02 |