Cleared Traditional

K904881 - DISPOSABLE YANKAUER SUCTION TUBE
(FDA 510(k) Clearance)

K904881 · Pilling Medical S.A. · General & Plastic Surgery

Mar 1991

Decision

133d

Days

Class 1

Risk

K904881 is an FDA 510(k) clearance for the DISPOSABLE YANKAUER SUCTION TUBE. This device is classified as a Cannula, Surgical, General & Plastic Surgery (Class I — General Controls, product code GEA).

Submitted by Pilling Medical S.A. (Par Caraman, France 31460, FR). The FDA issued a Cleared decision on March 6, 1991, 133 days after receiving the submission on October 24, 1990.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K904881 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 1990
Decision Date	March 06, 1991
Days to Decision	133 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—