VANGATOR II— 510(k) K952946

Name: FDA 510(k) clearance K952946
Creator: U.S. Food and Drug Administration
Published: 1995-11-29

Substantially Equivalent

Crow River Industries, Inc.

FDA 510(k) clearance K952946 for VANGATOR II, Substantially Equivalent on 1995-11-29. Applicant: Crow River Industries, Inc.. Device class: 2.

Clearance details

Applicant: Crow River Industries, Inc.
Product code: Code ING
Device class: Class 2
Regulation: 21 CFR 890.3930
Advisory panel: Physical Medicine
Date received: 1995-06-26
Decision date: 1995-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ING

product code ING

Death: 3
Total: 3

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.