EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT— 510(k) K013226

Name: FDA 510(k) clearance K013226
Creator: U.S. Food and Drug Administration
Published: 2001-12-20

Substantially Equivalent

Evenflo Company, Inc.

FDA 510(k) clearance K013226 for EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT, Substantially Equivalent on 2001-12-20. Applicant: Evenflo Company, Inc.. Device class: 1.

Clearance details

Applicant: Evenflo Company, Inc.
Product code: Code HGY
Device class: Class 1
Regulation: 21 CFR 884.5150
Advisory panel: Obstetrics/Gynecology
Date received: 2001-09-27
Decision date: 2001-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGY

view all

K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)2010-11-05
K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 11872004-04-05
K011519 — AMEDA HYGIENIKIT2001-08-15
K971231 — WHITE RIVER MINI MANUAL BREAST PUMP1997-05-19
K962828 — EVERT-IT1997-02-10

More clearances from Evenflo Company, Inc.

view all

K102600 — SIMPLYGO BREAST PUMP2010-12-22
K100435 — AMEDA PLATINUM BREAST PUMP2010-05-28
K092770 — SIMPLYGO HANDS FREE BREAST PUMP2009-10-09
K082307 — EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT2008-09-11
K053493 — BERRY FRUITY TEETHER2006-02-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.