Cleared Traditional

K843720 - COTTON TIPPED APPLICATORS, SINGLE
(FDA 510(k) Clearance)

K843720 · Abco Dealers, Inc. · General Hospital

Oct 1984

Decision

10d

Days

Class 1

Risk

K843720 is an FDA 510(k) clearance for the COTTON TIPPED APPLICATORS, SINGLE. This device is classified as a Applicator, Absorbent Tipped, Non-sterile (Class I - General Controls, product code KXF).

Submitted by Abco Dealers, Inc. (Walker, US). The FDA issued a Cleared decision on October 4, 1984, 10 days after receiving the submission on September 24, 1984.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6025.

Submission Details

510(k) Number	K843720 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 1984
Decision Date	October 04, 1984
Days to Decision	10 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—