The following data is part of a premarket notification filed by Drw Medical with the FDA for Exsalta.
Device ID | K221676 |
510k Number | K221676 |
Device Name: | Exsalta |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | DRW Medical 2710 Concord Road Aston, PA 19104 |
Contact | Dan Tatum |
Correspondent | Paul Dryden ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, FL 33704 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-06-09 |
Decision Date | 2022-09-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EXSALTA 98124091 not registered Live/Pending |
DRW Medical LLC 2023-08-09 |