Hydrofera Blue READY - Border
Dressing, Wound, Drug
Hydrofera, LLC
The following data is part of a premarket notification filed by Hydrofera, Llc with the FDA for Hydrofera Blue Ready - Border.
Pre-market Notification Details
| Device ID | K190268 |
| 510k Number | K190268 |
| Device Name: | Hydrofera Blue READY - Border |
| Classification | Dressing, Wound, Drug |
| Applicant | Hydrofera, LLC 340 Progress Drive Manchester, CT 06042 |
| Contact | Sean Anderson |
| Correspondent | Sean Anderson Hydrofera, LLC 340 Progress Drive Manchester, CT 06042 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-02-08 |
| Decision Date | 2019-11-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854827008421 | K190268 | 000 |
| 00854827008660 | K190268 | 000 |
| 00854827008684 | K190268 | 000 |
| 10854827008360 | K190268 | 000 |
| 10854827008377 | K190268 | 000 |
| 10854827008384 | K190268 | 000 |
| 10854827008391 | K190268 | 000 |
| 10854827008407 | K190268 | 000 |
| 10854827008414 | K190268 | 000 |
| 00854827008646 | K190268 | 000 |
Trademark Results [Hydrofera Blue READY - Border]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYDROFERA BLUE READY - BORDER 88753427 not registered Live/Pending |
HYDROFERA, LLC 2020-01-09 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.