White River Mini Manual Breast Pump

FDA 510(k) K971231 · White River Concepts

Substantially Equivalent

510(k) numberK971231

Submission

Device name
White River Mini Manual Breast Pump
Applicant
White River Concepts
San Clemente, CA, US
Received
April 3, 1997
Decision date
May 19, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K902552Gerber Precious Care Electric Breast PumpHGY · Traditional Gerber Products Co.09/26/1990SE

More from Gerber Products Co.

510(k)DeviceDecision
K970488Hydrocheck Micro FilterHGX · Traditional 11/04/1997SE
K964679White River Automatic Breast PumpHGX · Traditional 06/10/1997SE

Questions and answers

When was White River Mini Manual Breast Pump cleared by the FDA?

White River Mini Manual Breast Pump (K971231) received a 510(k) decision of Substantially Equivalent on May 19, 1997, 46 days after the submission was received.

What is the product code of K971231?

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