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FDA 510(k) Application Details - K030460
Device Classification Name
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510(K) Number
K030460
Device Name
MODIFICATION TO 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
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Date Received
02/12/2003
Decision Date
03/07/2003
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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