FDA 510(k) Application Details - K070930

Device Classification Name Staple, Implantable, Reprocessed

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510(K) Number K070930
Device Name Staple, Implantable, Reprocessed
Applicant STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE, MN 55369 US
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Contact DENNIS TOUSSAINT
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Regulation Number 878.4750

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Classification Product Code NLL
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Date Received 04/03/2007
Decision Date 10/18/2007
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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