RICHARDS INTRA-ARTICULAR SHAVER BLADES— 510(k) K830153

Substantially Equivalent

Richard'S Medical Equip., Inc.

FDA 510(k) clearance K830153 for RICHARDS INTRA-ARTICULAR SHAVER BLADES, Substantially Equivalent on 1983-02-28. Applicant: Richard'S Medical Equip., Inc..

Clearance details

Applicant
Richard'S Medical Equip., Inc.
Product code
Code GEY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GEY

product code GEY
Malfunction
7,488
Total
7,488

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.