Kaneson/Comfort Plus Manual Breast Pump

FDA 510(k) K813247 · Marshall Electronics, Inc.

Substantially Equivalent

510(k) numberK813247

Submission

Device name
Kaneson/Comfort Plus Manual Breast Pump
Applicant
Marshall Electronics, Inc.
Mchenry, IL, US
Received
November 18, 1981
Decision date
December 3, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HGY – Pump, Breast, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 884.5150
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HGY

510(k)DeviceApplicantDecision
K101538Handheld Manual Breast Pump (Avent Manual Breast Pump)HGY · Traditional Philips Electronics UK Limited11/05/2010SE
K032845Easy Comfort Deluxe Manual Breast Pump, Model 1187HGY · Traditional The First Years, Inc.04/05/2004SE
K013226Evenflo Comfort Ease Manual Breast Pump KitHGY · Traditional Evenflo Company, Inc.12/20/2001SE
K011519Ameda HygienikitHGY · Traditional Hollister, Inc.08/15/2001SE
K971231White River Mini Manual Breast PumpHGY · Traditional White River Concepts05/19/1997SE
K962828Evert-ItHGY · Traditional Genesis Industries, Inc.02/10/1997SE
K952034Medela's Foot PumpHGY · Traditional Medela, Inc.09/12/1995SE
K952035NipletteHGY · Traditional Avent America, Inc.07/28/1995SE
K925738White River Manual Breast PumpHGY · Traditional White River (Tm)05/04/1994SE
K912355Mothers Touch One Hand Breast PumpHGY · Traditional Hollister, Inc.12/10/1993SE

More from Hollister, Inc.

510(k)DeviceDecision
K790411Auto Trauma KitKME · Traditional 06/01/1979SE
K780023Black Bag, ElectronicLDE · Traditional 02/21/1978SE

Questions and answers

When was Kaneson/Comfort Plus Manual Breast Pump cleared by the FDA?

Kaneson/Comfort Plus Manual Breast Pump (K813247) received a 510(k) decision of Substantially Equivalent on December 3, 1981, 15 days after the submission was received.

What is the product code of K813247?

The FDA product code is HGY – Pump, Breast, Non-Powered, a Class I (low risk) device regulated under 21 CFR 884.5150.