HOLDER, PEDIATRIC POSITION— 510(k) K922288

Name: FDA 510(k) clearance K922288
Creator: U.S. Food and Drug Administration
Published: 1993-02-10

Substantially Equivalent

Yamashita and Hemsley Business Trust

FDA 510(k) clearance K922288 for HOLDER, PEDIATRIC POSITION, Substantially Equivalent on 1993-02-10. Applicant: Yamashita and Hemsley Business Trust. Device class: 1.

Clearance details

Applicant: Yamashita and Hemsley Business Trust
Product code: Code BWN
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1992-05-15
Decision date: 1993-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medford, OR, US

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Adverse events under product code BWN

product code BWN

Other: 1
Total: 1

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.