FDA 510(k) Application Details - K021835

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K021835
Device Name Mesh, Surgical, Polymeric
Applicant BRENNEN MEDICAL, INC.
1290 HAMMOND RD.
ST. PAUL, MN 55110 US
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Contact PHILLIP B LAWIN
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 06/04/2002
Decision Date 10/17/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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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