Cleared Traditional

K760420 - FILTER, VACUUM LINE LINEGUARD
(FDA 510(k) Clearance)

Aug 1976
Decision
17d
Days
Class 2
Risk

K760420 is an FDA 510(k) clearance for the FILTER, VACUUM LINE LINEGUARD. This device is classified as a System, Simulation, Radiation Therapy (Class II - Special Controls, product code KPQ).

Submitted by Diemolding Corp. (Mchenry, US). The FDA issued a Cleared decision on August 23, 1976, 17 days after receiving the submission on August 6, 1976.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5840.

Submission Details

510(k) Number K760420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1976
Decision Date August 23, 1976
Days to Decision 17 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code KPQ — System, Simulation, Radiation Therapy
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.5840

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