Cleared Traditional

TIP, DENTAL SUCTION APPARATUS

K870599 · Military Engineering, Inc. · Dental
Mar 1987
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K870599 is an FDA 510(k) clearance for the TIP, DENTAL SUCTION APPARATUS, a Mouthpiece, Saliva Ejector (Class I — General Controls, product code DYN), submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 23, 1987, 41 days after receiving the submission on February 10, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K870599 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1987
Decision Date March 23, 1987
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code DYN — Mouthpiece, Saliva Ejector
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640