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510(k) K001576

Device
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
Applicant
PROSURG, INC.
510(k) number
K001576
Product code
NBV  
Decision
Substantially Equivalent (SESE)
Decision date
2000-12-28
Date received
2000-05-22
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
LEE BUI
Address
2193 Trade Zone Blvd. San Jose CA US 95131 95131

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
K043480ENHANCE CLITORAL STIMULATION AIDGynavations, Inc.2005-06-08
DEN000006EROS-CLITORAL THERAPY DEVICE (CTD)Urometrics, Inc.2000-04-28

Legacy Summary#

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FDA Review#

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