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510(k) K002233

Device
BVI SLING
Applicant
BIO-VASCULAR, INC.
510(k) number
K002233
Product code
PAJ  
Decision
Substantially Equivalent (SESE)
Decision date
2000-10-13
Date received
2000-07-24
Regulation
878.3300
Classification name
Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Medical specialty
General & Plastic Surgery
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAISY P SIN
Address
2575 University Ave. St. Paul MN US 55114 55114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PAJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K051190XENFORM SOFT TISSUE REPAIR MATRIXTei Biosciences, Inc.2005-06-10

Legacy Summary#

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FDA Review#

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