Cleared Traditional

KIT PAK INCONTINENT SKIN CARE KIT

K932310 · Kit Pak, Inc. · Gastroenterology & Urology
Jun 1994
Decision
386d
Days
Class 1
Risk

About This 510(k) Submission

K932310 is an FDA 510(k) clearance for the KIT PAK INCONTINENT SKIN CARE KIT, a Garment, Protective, For Incontinence (Class I — General Controls, product code EYQ), submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on June 1, 1994, 386 days after receiving the submission on May 11, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5920.

Submission Details

510(k) Number K932310 FDA.gov
FDA Decision Cleared SEKD
Date Received May 11, 1993
Decision Date June 01, 1994
Days to Decision 386 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code EYQ — Garment, Protective, For Incontinence
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5920

Similar Devices — EYQ Garment, Protective, For Incontinence

All 55
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
K950784 · Advanced Bioresearch Assoc. · May 1995
DEODORIZING AND SOUND MUFFLING ANAL PAD
K903342 · Biological Resistance, Inc. · Oct 1990
LIB SYSTEM, BABY/ADULT DIAPER
K891686 · Intera Corp. · May 1989
INTERA SHIELD AND INTERA UNDERGARMENT
K885185 · Intera Corp. · Feb 1989
DRIPRIDE PROVIDE SLIM
K883894 · Weyerhaeuser Co. · Jan 1989
DRIPRIDE ULTRA INCONTINENT PAD
K883895 · Weyerhaeuser Co. · Jan 1989