Cleared Traditional

K882739 - INTERTECH LARGE VOLUME WATER TRAP (LVW)
(FDA 510(k) Clearance)

Aug 1988
Decision
39d
Days
Class 1
Risk

K882739 is an FDA 510(k) clearance for the INTERTECH LARGE VOLUME WATER TRAP (LVW). This device is classified as a Drain, Tee (water Trap) (Class I - General Controls, product code BYH).

Submitted by Intertech Resources, Inc. (Chicago, US). The FDA issued a Cleared decision on August 9, 1988, 39 days after receiving the submission on July 1, 1988.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5995.

Submission Details

510(k) Number K882739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1988
Decision Date August 09, 1988
Days to Decision 39 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BYH — Drain, Tee (water Trap)
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5995

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