Cleared Traditional

K013226 - EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
(FDA 510(k) Clearance)

K013226 · Evenflo Company, Inc. · Obstetrics & Gynecology device

Dec 2001

Decision

84d

Days

Class 1

Risk

K013226 is an FDA 510(k) clearance for the EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT. This device is classified as a Pump, Breast, Non-powered (Class I - General Controls, product code HGY).

Submitted by Evenflo Company, Inc. (Canton, US). The FDA issued a Cleared decision on December 20, 2001, 84 days after receiving the submission on September 27, 2001.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5150.

Submission Details

510(k) Number	K013226 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 27, 2001
Decision Date	December 20, 2001
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement