20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE— 510(k) K972185
Substantially Equivalent for Some IndicationsSteripak, Ltd.
FDA 510(k) clearance K972185 for 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE, Substantially Equivalent for Some Indications on 1998-03-05. Applicant: Steripak, Ltd..
Clearance details
- Applicant
- Steripak, Ltd.
- Product code
- Code FRO
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Runcorn, Cheshire, GB
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.