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510(k) K955589

Device
FERTICARE PERSONAL THERAPEUTIC VIBRATOR
Applicant
MULTICEPT APS
510(k) number
K955589
Product code
KXQ  
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-11
Date received
1995-12-07
Regulation
884.5960
Classification name
Vibrator For Therapeutic Use, Genital
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
S, K MCGARVEY
Address
Vallerodvange 2 2960 Rungsted Kyst,Denmark DK

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KXQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K142304Viberect Penile Vibratory Stimulation DeviceReflexonic, LLC2014-10-03
K110566VIBERECT PENILE VIBRATORY STIMULATION DEVICEReflexonic, LLC2011-06-24
K010096MULTI CARE THERAPEUTIC VIBRATORMulticept A/S2001-03-05

Legacy Summary#

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FDA Review#

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