Cleared Traditional

K780929 - COTTON TIPPED POINT
(FDA 510(k) Clearance)

K780929 · Young Dental Manufacturing Co. 1, LLC · General Hospital
Jun 1978
Decision
25d
Days
Class 1
Risk

K780929 is an FDA 510(k) clearance for the COTTON TIPPED POINT, a Applicator, Absorbent Tipped, Non-sterile (Class I — General Controls, product code KXF), submitted by Young Dental Manufacturing Co. 1, LLC (Mchenry, US). The FDA issued a Cleared decision on June 30, 1978, 25 days after receiving the submission on June 5, 1978. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6025.

Submission Details

510(k) Number K780929 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1978
Decision Date June 30, 1978
Days to Decision 25 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KXF — Applicator, Absorbent Tipped, Non-sterile
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6025