Silverlon Wound Contact, Burn Contact Dressings— 510(k) K190343
Substantially EquivalentArgentum Medical, LLC
FDA 510(k) clearance K190343 for Silverlon Wound Contact, Burn Contact Dressings, Substantially Equivalent on 2019-07-18. Applicant: Argentum Medical, LLC. Device class: Unclassified.
Clearance details
- Applicant
- Argentum Medical, LLC
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Geneva, IL, US
Recent devices under product code FRO
view allMore clearances from Argentum Medical, LLC
view all- K241225 — Silverlon® Wound Contact, Burn Contact Dressing
- K180570 — Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)
- K141033 — SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV
- K122817 — SILVERLON ISLAND WOUND DRESSING
- K053590 — SILVERLON CA (CALCIUM ALGINATE)
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.