SURGICAL LIGHTING-CENTRA 450— 510(k) K902864

Substantially Equivalent

Sds Dental, Inc.

FDA 510(k) clearance K902864 for SURGICAL LIGHTING-CENTRA 450, Substantially Equivalent on 1990-09-10. Applicant: Sds Dental, Inc..

Clearance details

Applicant
Sds Dental, Inc.
Product code
Code FSY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fort Lauderdale, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FSY

product code FSY
Malfunction
2,759
Other
1
Total
2,760

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.