FDA 510(k) Application Details - K002233

Device Classification Name

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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
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Regulation Number

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Classification Product Code PAJ
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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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