3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95— 510(k) K955382
Substantially Equivalent3M Company
FDA 510(k) clearance K955382 for 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95, Substantially Equivalent on 1996-05-01. Applicant: 3M Company. Device class: 2.
Clearance details
- Applicant
- 3M Company
- 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
- St. Paul, MN, US
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More clearances from 3M Company
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- K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD) +3 more
- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
- K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
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.