Kit Pak Incontinent Skin Care Kit

FDA 510(k) K932310 · Kit Pak, Inc.

Unknown

510(k) numberK932310

Submission

Device name
Kit Pak Incontinent Skin Care Kit
Applicant
Kit Pak, Inc.
Elk Grove Village, IL, US
Received
May 11, 1993
Decision date
June 1, 1994
Decision
Unknown (SEKD)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EYQ – Garment, Protective, For Incontinence
Device class
Class I (low risk)
Regulation
21 CFR 876.5920
Specialty
Gastroenterology, Urology

Other 510(k)s with product code EYQ

510(k)DeviceApplicantDecision
K950784Dristar Urinary Incontinence Management SystemEYQ · Traditional Advanced Bioresearch Assoc.05/03/1995SE
K903342Deodorizing and Sound Muffling Anal PadEYQ · Traditional Biological Resistance, Inc.10/23/1990SE
K891686Lib System, Baby/Adult DiaperEYQ · Traditional Intera Corp.05/31/1989SE
K885185Intera Shield and Intera UndergarmentEYQ · Traditional Intera Corp.02/08/1989SE
K883895Dripride Ultra Incontinent PadEYQ · Traditional Weyerhaeuser Co.01/30/1989SE
K883894Dripride Provide SlimEYQ · Traditional Weyerhaeuser Co.01/30/1989SE
K883787Reusable Adult Incontinent DiaperEYQ · Traditional Intera Corp.11/07/1988SE
K882418Dry Comfort UndergarmentEYQ · Traditional Health Tec, Inc.09/29/1988SE
K880454At Ease Stress PadEYQ · Traditional Hospital Specialty Co.06/16/1988SE
K880455At Ease Adult DiaperEYQ · Traditional Hospital Specialty Co.04/14/1988SE

More from Hospital Specialty Co.

510(k)DeviceDecision
K942959Kit Pak Wet Saline DressingFRO · Traditional 02/14/1995SN
K941499Kit Pak Dressing Change TrayKGX · Traditional 07/20/1994SEKD
K934080Urinary Drainage BagEYT · Traditional 05/18/1994SE
K931013Foley Catheter TrayKNY · Traditional 08/09/1993SE
K923905Wound Dressing KitMCY · Traditional 07/02/1993SEKD
K924051Kit Pak I.V. Start KitLYY · Traditional 06/22/1993SEKD
K923906Foley Insertion TrayKOD · Traditional 06/22/1993SEKD
K922051Kit Pak's Flushing KitKOD · Traditional 06/17/1993SESK
K925281Kit Pak Urinary Care SuppliesKNY · Traditional 04/19/1993SESK
K900148Kit Pak Irrigation TrayEYN · Traditional 04/23/1990SEKD

Questions and answers

When was Kit Pak Incontinent Skin Care Kit cleared by the FDA?

Kit Pak Incontinent Skin Care Kit (K932310) received a 510(k) decision of Unknown on June 1, 1994, 386 days after the submission was received.

What is the product code of K932310?

The FDA product code is EYQ – Garment, Protective, For Incontinence, a Class I (low risk) device regulated under 21 CFR 876.5920.