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510(k) K080200

Device
WATER WORKS DOUCHING DEVICE
Applicant
ABBOTT RESEARCH GROUP, INC.
510(k) number
K080200
Product code
HED  
Decision
Substantially Equivalent (SESE)
Decision date
2008-07-10
Date received
2008-01-25
Regulation
884.5900
Classification name
Douche Apparatus, Vaginal, Therapeutic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROSINA ROBINSON
Address
49 Plain St. North Attleboro MA US 02760 02760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HED  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K800954DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVIDThe Healthcare Group Laboratories, Inc.1980-10-03
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

Legacy Summary#

summary

FDA Review#

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