FDA 510(k) Application Details - K993459

Device Classification Name

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510(K) Number K993459
Device Name MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
Applicant ADVANCED UROSCIENCE, INC.
1290 HAMMOND RD.
ST. PAUL, MN 55110 US
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Contact KAREN E PETERSON
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Regulation Number

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Classification Product Code PAG
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Date Received 10/13/1999
Decision Date 11/05/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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