The following data is part of a premarket notification filed by Applied Tissue Technologies Llc with the FDA for Applied Tissue Technologies Pwd™ Platform Wound Dressing.
Device ID | K182409 |
510k Number | K182409 |
Device Name: | Applied Tissue Technologies PWD™ Platform Wound Dressing |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-04 |
Decision Date | 2019-01-11 |
Summary: | summary |