Cleared Traditional

K872459 - AN3100 MULHOLLAND DRAIN
(FDA 510(k) Clearance)

K872459 · H.W. Andersen Products, Inc. · General & Plastic Surgery

Jul 1987

Decision

28d

Days

Class 1

Risk

K872459 is an FDA 510(k) clearance for the AN3100 MULHOLLAND DRAIN. This device is classified as a Catheter, Ventricular, General & Plastic Surgery (Class I — General Controls, product code GBS).

Submitted by H.W. Andersen Products, Inc. (Oyster Bay, US). The FDA issued a Cleared decision on July 21, 1987, 28 days after receiving the submission on June 23, 1987.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number	K872459 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 1987
Decision Date	July 21, 1987
Days to Decision	28 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—