The following data is part of a premarket notification filed by Argentis Biomedical Incorporated with the FDA for Silvermed Antimicrobial Silver Hydrogel.
| Device ID | K073019 |
| 510k Number | K073019 |
| Device Name: | SILVERMED ANTIMICROBIAL SILVER HYDROGEL |
| Classification | Dressing, Wound, Drug |
| Applicant | ARGENTIS BIOMEDICAL INCORPORATED 26 CHESTNUT RIDGE ROAD #12 Montvale, NJ 07645 |
| Contact | Toni Miller |
| Correspondent | Toni Miller ARGENTIS BIOMEDICAL INCORPORATED 26 CHESTNUT RIDGE ROAD #12 Montvale, NJ 07645 |
| 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 | 2007-10-25 |
| Decision Date | 2008-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00366977141581 | K073019 | 000 |
| 00366977141031 | K073019 | 000 |
| 00366977140454 | K073019 | 000 |