Cleared Traditional

K872656 - LEAD GLASS SHIELDS (FDA 510(k) Clearance)

Jul 1987
Decision
9d
Days
Class 1
Risk

K872656 is an FDA 510(k) clearance for the LEAD GLASS SHIELDS. This device is classified as a Holder, Syringe, Lead (Class I - General Controls, product code IWR).

Submitted by Viox Corp. (Seattle, US). The FDA issued a Cleared decision on July 16, 1987, 9 days after receiving the submission on July 7, 1987.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K872656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1987
Decision Date July 16, 1987
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code IWR — Holder, Syringe, Lead
Device Class Class I - General Controls
CFR Regulation 21 CFR 892.6500