The following data is part of a premarket notification filed by Acera Surgical, Inc. with the FDA for Restrata Wound Matrix.
| Device ID | K170300 |
| 510k Number | K170300 |
| Device Name: | Restrata Wound Matrix |
| Classification | Dressing, Wound, Drug |
| Applicant | Acera Surgical, Inc. 10880 Baur Blvd. St. Louis, MO 63132 |
| Contact | Tamas Kovacs |
| Correspondent | Linda Braddon Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-31 |
| Decision Date | 2017-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854258006129 | K170300 | 000 |