BASIC SKIN PREP TRAY— 510(k) K932361

Name: FDA 510(k) clearance K932361
Creator: U.S. Food and Drug Administration
Published: 1993-12-13

Unknown

Mcbar Industries

FDA 510(k) clearance K932361 for BASIC SKIN PREP TRAY, Unknown on 1993-12-13. Applicant: Mcbar Industries. Device class: 2.

Clearance details

Applicant: Mcbar Industries
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 1993-03-10
Decision date: 1993-12-13
Decision: Unknown
Clearance type: Traditional
Location: Beverly, MA, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.