3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE— 510(k) K965043

Name: FDA 510(k) clearance K965043
Creator: U.S. Food and Drug Administration
Published: 1997-03-10

Substantially Equivalent

Minnesota Mining and Mfg. Co.

FDA 510(k) clearance K965043 for 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE, Substantially Equivalent on 1997-03-10. Applicant: Minnesota Mining and Mfg. Co.. Device class: 2.

Clearance details

Applicant: Minnesota Mining and Mfg. Co.
Product code: Code FXX
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1996-12-17
Decision date: 1997-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FXX

view all

More clearances from Minnesota Mining and Mfg. Co.

view all

K013228 — 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR2002-01-18
K000355 — 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR2000-08-23
K000690 — 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE2000-05-17
K990482 — 3M CLINPRO PROPHY PASTE, MODEL 126111999-05-13
K961848 — 3M LITTMANN ELECTRONIC STETHOSCOPE1997-09-26

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.