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HED — Douche Apparatus, Vaginal, Therapeutic Class I

FDA Device Classification

Classification Details

Product Code
HED
Device Class
Class I
Regulation Number
884.5900
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K080200abbott research groupWATER WORKS DOUCHING DEVICEJuly 10, 2008
K030056corisen groupWORRY-REMOVER IRRIGATORApril 22, 2003
K000736goomi ehwaLA JOIEAugust 8, 2000
K902830orion life systemsPERI-BOTTLEAugust 6, 1990
K881216geneva laboratoriesGENT-L-KARE VAGINAL IRRIGATION SETJune 7, 1988
K854595pa medicalP.A. MEDICAL VAGINAL IRRIGATION SET #1130January 13, 1986
K841710mac lee medical productsMAC LEE VAGINAL IRRIGATORJune 19, 1984
K831667snow willowFEMININE HYGIENE DEVICESeptember 12, 1983
K800956healthcare group laboratoriesDOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BENOctober 3, 1980
K800954healthcare group laboratoriesDOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVIDOctober 3, 1980
K800957healthcare group laboratoriesDOUCHE UNIT-1500 ML DISP. CONTAINERJuly 14, 1980
K781207chatten drug and chemicalDOUCHE KIT, SOMETHING PERSONALAugust 10, 1978