FDA.reportPublic FDA data

510(k) K800954

Device
Douche Tray-dispos. Vaginal Tray W/povid
Applicant
THE HEALTHCARE GROUP LABORATORIES, INC.
510(k) number
K800954
Product code
HED
Decision
Substantially Equivalent (SESE)
Decision date
1980-10-03
Date received
1980-04-23
Regulation
884.5900
Classification name
Douche Apparatus, Vaginal, Therapeutic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HED#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K080200WATER WORKS DOUCHING DEVICEAbbott Research Group, Inc.2008-07-10
K030056WORRY-REMOVER IRRIGATORCorisen Group, Ltd.2003-04-22
K000736LA JOIEGoomi Ehwa, Inc.2000-08-08
K902830PERI-BOTTLEOrion Life Systems, Inc.1990-08-06
K881216GENT-L-KARE VAGINAL IRRIGATION SETGeneva Laboratories, Inc.1988-06-07
K854595P.A. MEDICAL VAGINAL IRRIGATION SET #1130Pa Medical Corp.1986-01-13
K841710MAC LEE VAGINAL IRRIGATORMac Lee Medical Products1984-06-19
K831667FEMININE HYGIENE DEVICESnow Willow Co.1983-09-12
K800956DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BENThe Healthcare Group Laboratories, Inc.1980-10-03
K800957DOUCHE UNIT-1500 ML DISP. CONTAINERThe Healthcare Group Laboratories, Inc.1980-07-14
K781207DOUCHE KIT, SOMETHING PERSONALChatten Drug & Chemical Co.1978-08-10