The following data is part of a premarket notification filed by Argentum Medical, Llc with the FDA for Silverlon Wound Contact, Burn Contact Dressings.
Device ID | K190343 |
510k Number | K190343 |
Device Name: | Silverlon Wound Contact, Burn Contact Dressings |
Classification | Dressing, Wound, Drug |
Applicant | Argentum Medical, LLC 2571 Kaneville CT Geneva, IL 60134 |
Contact | Aftab Ahmad |
Correspondent | Aftab Ahmad Argentum Medical, LLC 2571 Kaneville CT Geneva, IL 60134 |
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 | 2019-02-14 |
Decision Date | 2019-07-18 |
Summary: | summary |