ADT MINI PERITONEAL LAVAGE KIT— 510(k) K800422

Substantially Equivalent

A.D.T. Lab Industries

FDA 510(k) clearance K800422 for ADT MINI PERITONEAL LAVAGE KIT, Substantially Equivalent on 1980-03-12. Applicant: A.D.T. Lab Industries. Device class: 1.

Clearance details

Applicant
A.D.T. Lab Industries
Product code
Code GBW
Device class
Class 1
Regulation
21 CFR 878.4200
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 ↗

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Adverse events under product code GBW

product code GBW
Death
6
Total
6

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.