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510(k) K043480

Device
ENHANCE CLITORAL STIMULATION AID
Applicant
GYNAVATIONS, INC.
510(k) number
K043480
Product code
NBV  
Decision
Substantially Equivalent (SESE)
Decision date
2005-06-08
Date received
2004-12-16
Regulation
884.5970
Classification name
Device, Engorgement, Clitoral
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
DAVID GLOTH
Address
665 Salem St. Malden MA US 02148 02148

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NBV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001576EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPYProsurg, Inc.2000-12-28
DEN000006EROS-CLITORAL THERAPY DEVICE (CTD)Urometrics, Inc.2000-04-28

Legacy Summary#

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FDA Review#

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