Cleared Traditional

FIRST AID KIT(S)

K963298 · Vector, Inc. · Anesthesiology

Nov 1996

Decision

77d

Days

Class 1

Risk

About This 510(k) Submission

K963298 is an FDA 510(k) clearance for the FIRST AID KIT(S), a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Vector, Inc. (Orchard Park, US). The FDA issued a Cleared decision on November 6, 1996, 77 days after receiving the submission on August 21, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number	K963298 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 1996
Decision Date	November 06, 1996
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement