Cleared Traditional

SALINE SOLUTION- STERILE

K922033 · Trinity Laboratories, Inc. · Anesthesiology
Jul 1992
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K922033 is an FDA 510(k) clearance for the SALINE SOLUTION- STERILE, a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I — General Controls, product code CCQ), submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on July 21, 1992, 81 days after receiving the submission on May 1, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5640.

Submission Details

510(k) Number K922033 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1992
Decision Date July 21, 1992
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CCQ — Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5640

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