FILTER FLOW MASK CAT. #350— 510(k) K812997
Substantially EquivalentEldredge Mfg. Co.
FDA 510(k) clearance K812997 for FILTER FLOW MASK CAT. #350, Substantially Equivalent on 1981-12-03. Applicant: Eldredge Mfg. Co.. Device class: 2.
Clearance details
- Applicant
- Eldredge Mfg. Co.
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Eldredge Mfg. Co.
view allAdverse 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.