PEDO CUSH PEDO CUDDLE— 510(k) K972446

Name: FDA 510(k) clearance K972446
Creator: U.S. Food and Drug Administration
Published: 1997-11-13

Substantially Equivalent

Cavity Free Kids, Inc.

FDA 510(k) clearance K972446 for PEDO CUSH PEDO CUDDLE, Substantially Equivalent on 1997-11-13. Applicant: Cavity Free Kids, Inc.. Device class: 1.

Clearance details

Applicant: Cavity Free Kids, Inc.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 1997-06-30
Decision date: 1997-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.