GASTRIC AND RECTAL CATHETERS— 510(k) K973844

Substantially Equivalent

G & J Electronics, Inc.

FDA 510(k) clearance K973844 for GASTRIC AND RECTAL CATHETERS, Substantially Equivalent on 1999-06-04. Applicant: G & J Electronics, Inc.. Device class: 2.

Clearance details

Applicant
G & J Electronics, Inc.
Product code
Code FFX
Device class
Class 2
Regulation
21 CFR 876.1725
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Toronto, Ontario, CA
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FFX

product code FFX
Other
1
Total
1

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.