Cleared Traditional

K873038 - TECHTON PROTECTIVE PAD (FDA 510(k) Clearance)

Apr 1989
Decision
608d
Days
Class 1
Risk

K873038 is an FDA 510(k) clearance for the TECHTON PROTECTIVE PAD. This device is classified as a Curtain, Protective, Radiographic (Class I - General Controls, product code IWQ).

Submitted by Techton, Inc. (Albuquerque, US). The FDA issued a Cleared decision on April 3, 1989, 608 days after receiving the submission on August 4, 1987.

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

Submission Details

510(k) Number K873038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date April 03, 1989
Days to Decision 608 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code IWQ — Curtain, Protective, Radiographic
Device Class Class I - General Controls
CFR Regulation 21 CFR 892.6500