Evert-It

FDA 510(k) K962828 · Genesis Industries, Inc.

Substantially Equivalent

510(k) numberK962828

Submission

Device name
Evert-It
Applicant
Genesis Industries, Inc.
Elmwood, WI, US
Received
July 19, 1996
Decision date
February 10, 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

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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
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

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K833280Supra Ap Choice 83EIS · Traditional 12/26/1983SE
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Questions and answers

When was Evert-It cleared by the FDA?

Evert-It (K962828) received a 510(k) decision of Substantially Equivalent on February 10, 1997, 206 days after the submission was received.

What is the product code of K962828?

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