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FDA 510(k) Application Details - K982403
Device Classification Name
More FDA Info for this Device
510(K) Number
K982403
Device Name
BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
Applicant
BRENNEN MEDICAL, INC.
1290 HAMMOND RD.
ST. PAUL, MN 55110 US
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Contact
KENNETH B HERLAND
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Regulation Number
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Classification Product Code
PAG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/10/1998
Decision Date
09/22/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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