UNNA BOOT DRESSING W/CALAMINE— 510(k) K883224
Substantially Equivalent for Some IndicationsGraham-Field, Inc.
FDA 510(k) clearance K883224 for UNNA BOOT DRESSING W/CALAMINE, Substantially Equivalent for Some Indications on 1989-01-05. Applicant: Graham-Field, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Graham-Field, Inc.
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Hauppauge, NY, US
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- K901947 — CARDISUNY 501AB
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.