FDA 510(k) Application Details - K050086

Device Classification Name Dressing, Wound, Drug

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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
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Regulation Number 000.0000

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Classification Product Code FRO
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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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