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FDA 510(k) Application Details - K002233
Device Classification Name
More FDA Info for this Device
510(K) Number
K002233
Device Name
BVI SLING
Applicant
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL, MN 55114-1024 US
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Contact
DAISY P SIN
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PAJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/24/2000
Decision Date
10/13/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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