Cleared Traditional

VACSTAR

K942698 · Air Techniques, Inc. · Dental
Mar 1995
Decision
282d
Days
Class 1
Risk

About This 510(k) Submission

K942698 is an FDA 510(k) clearance for the VACSTAR, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on March 17, 1995, 282 days after receiving the submission on June 8, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K942698 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1994
Decision Date March 17, 1995
Days to Decision 282 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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