The following data is part of a premarket notification filed by Virchow Biotech Pvt. Ltd. with the FDA for Ionsil Gel.
| Device ID | K132326 |
| 510k Number | K132326 |
| Device Name: | IONSIL GEL |
| Classification | Dressing, Wound, Drug |
| Applicant | VIRCHOW BIOTECH PVT. LTD. 5903 SE MILWAUKIE AVENUE Portland, OR 97202 |
| Contact | Bruce Gibbins, Phd. |
| Correspondent | Bruce Gibbins, Phd. 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 | No |
| Date Received | 2013-07-26 |
| Decision Date | 2014-08-21 |
| Summary: | summary |