BLUE PLANET LENS FOG REDUCTION & CLEANING KIT— 510(k) K941648

Substantially Equivalent

Blue Planet Industries, Inc.

FDA 510(k) clearance K941648 for BLUE PLANET LENS FOG REDUCTION & CLEANING KIT, Substantially Equivalent on 1994-05-17. Applicant: Blue Planet Industries, Inc..

Clearance details

Applicant
Blue Planet Industries, Inc.
Product code
Code FEB
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plymouth, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FEB

product code FEB
Malfunction
3,879
Total
3,879

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.