Cleared Traditional

K894755 - ASTRA DISPOSABLE SPRAY CANNULA
(FDA 510(k) Clearance)

K894755 · Astra Pharmaceutical Products, Inc. · Anesthesiology
Jan 1990
Decision
169d
Days
Class 2
Risk

K894755 is an FDA 510(k) clearance for the ASTRA DISPOSABLE SPRAY CANNULA, a Applicator (laryngo-tracheal), Topical Anesthesia (Class II — Special Controls, product code CCT), submitted by Astra Pharmaceutical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on January 12, 1990, 169 days after receiving the submission on July 27, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5170.

Submission Details

510(k) Number K894755 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1989
Decision Date January 12, 1990
Days to Decision 169 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code CCT — Applicator (laryngo-tracheal), Topical Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5170

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