HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES— 510(k) K905086

Name: FDA 510(k) clearance K905086
Creator: U.S. Food and Drug Administration
Published: 1990-12-03

Substantially Equivalent

Hpi, Inc.

FDA 510(k) clearance K905086 for HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES, Substantially Equivalent on 1990-12-03. Applicant: Hpi, Inc.. Device class: 1.

Clearance details

Applicant: Hpi, Inc.
Product code: Code IWP
Device class: Class 1
Regulation: 21 CFR 892.6500
Advisory panel: Radiology
Date received: 1990-11-14
Decision date: 1990-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton Centre, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.