Cleared Traditional

K884359 - UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.
(FDA 510(k) Clearance)

K884359 · Automatic Liquid Packaging, Inc. · Anesthesiology

Dec 1988

Decision

64d

Days

Class 2

Risk

K884359 is an FDA 510(k) clearance for the UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA., a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on December 20, 1988, 64 days after receiving the submission on October 17, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K884359 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 1988
Decision Date	December 20, 1988
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—