MILL-ROSE PERCUTANEOUS PROCEDURAL KIT— 510(k) K935858

Unknown

Mill-Rose Laboratory

FDA 510(k) clearance K935858 for MILL-ROSE PERCUTANEOUS PROCEDURAL KIT, Unknown on 1994-02-22. Applicant: Mill-Rose Laboratory.

Clearance details

Applicant: Mill-Rose Laboratory
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 1993-12-08
Decision date: 1994-02-22
Decision: Unknown
Clearance type: Traditional
Location: Mentor, OH, US

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.