MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)— 510(k) K093179
Substantially EquivalentH&H Research Company
FDA 510(k) clearance K093179 for MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002), Substantially Equivalent on 2010-07-14. Applicant: H&H Research Company.
Clearance details
- Applicant
- H&H Research Company
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Los Angeles, CA, US
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
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.