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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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More FDA Info for this Product Code
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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