DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)— 510(k) K080497
Substantially EquivalentDerma Sciences Canada, Inc.
FDA 510(k) clearance K080497 for DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG), Substantially Equivalent on 2008-06-27. Applicant: Derma Sciences Canada, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Derma Sciences Canada, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, Orntario, CA
Recent devices under product code FRO
view allMore clearances from Derma Sciences Canada, Inc.
view allAdverse 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 →
Recalls naming K080497
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080497.
Data sourced from openFDA. This site is unofficial and independent of the FDA.