Cleared Traditional

DRY TIPS

K890734 · Microcopy, Div. Neo-Flo, Inc. · Dental
Mar 1989
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K890734 is an FDA 510(k) clearance for the DRY TIPS, a Absorber, Saliva, Paper (Class I — General Controls, product code KHR), submitted by Microcopy, Div. Neo-Flo, Inc. (Kennesaw, US). The FDA issued a Cleared decision on March 10, 1989, 25 days after receiving the submission on February 13, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.6050.

Submission Details

510(k) Number K890734 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 1989
Decision Date March 10, 1989
Days to Decision 25 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code KHR — Absorber, Saliva, Paper
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6050