SHAVE PREP TRAY— 510(k) K855132

Substantially Equivalent

Dynarex Corp.

FDA 510(k) clearance K855132 for SHAVE PREP TRAY, Substantially Equivalent on 1986-01-24. Applicant: Dynarex Corp..

Clearance details

Applicant: Dynarex Corp.
Product code: Code MDM
Advisory panel: General, Plastic Surgery
Date received: 1985-12-23
Decision date: 1986-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brewster, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.