Restrata®
Dressing, Wound, Drug
Acera Surgical, Inc.
The following data is part of a premarket notification filed by Acera Surgical, Inc. with the FDA for Restrata®.
Pre-market Notification Details
| Device ID | K193583 |
| 510k Number | K193583 |
| Device Name: | Restrata® |
| Classification | Dressing, Wound, Drug |
| Applicant | Acera Surgical, Inc. 10880 Baur Blvd. St. Louis, MO 63132 |
| Contact | Lily Jeng |
| Correspondent | Linda Braddon Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-09-25 |
Trademark Results [Restrata]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESTRATA 97129598 not registered Live/Pending |
Restrata Solutions Limited 2021-11-17 |
 RESTRATA 87336705 5361337 Live/Registered |
Acera Surgical, Inc. 2017-02-15 |
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