The following data is part of a premarket notification filed by Virchow Biotech Pvt. Ltd. with the FDA for Donasorb Silver Wound Dressing.
| Device ID | K153565 |
| 510k Number | K153565 |
| Device Name: | DONASORB SILVER WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | VIRCHOW BIOTECH PVT. LTD. 5903, SE MILWAUKIE AVENUE Portland, OR 97202 |
| Contact | Bruce Gibbins |
| Correspondent | Bruce Gibbins VIRCHOW BIOTECH PVT. LTD. 5903, SE MILWAUKIE AVENUE Portland, OR 97202 |
| 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 | 2015-12-14 |
| Decision Date | 2016-09-22 |
| Summary: | summary |