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FDA 510(k) Application Details - K050086
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K050086
Device Name
Dressing, Wound, Drug
Applicant
BRENNEN MEDICAL, INC.
1290 HAMMOND RD.
ST. PAUL, MN 55110 US
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Contact
KENNETH B HERLAND
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
01/13/2005
Decision Date
02/17/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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