Cleared Traditional

DUAL SPRAY MINISPACER

K955805 · Thayer Medical Corp. · Anesthesiology
Mar 1996
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K955805 is an FDA 510(k) clearance for the DUAL SPRAY MINISPACER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on March 21, 1996, 90 days after receiving the submission on December 22, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K955805 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1995
Decision Date March 21, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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