GENNY DENNY IV SHIELD— 510(k) K905735

Name: FDA 510(k) clearance K905735
Creator: U.S. Food and Drug Administration
Published: 1991-01-18

Substantially Equivalent

Tadco, Inc.

FDA 510(k) clearance K905735 for GENNY DENNY IV SHIELD, Substantially Equivalent on 1991-01-18. Applicant: Tadco, Inc.. Device class: 1.

Clearance details

Applicant: Tadco, Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1990-12-24
Decision date: 1991-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmington, NM, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.