FDA 510(k) Application Details - K143562

Device Classification Name Scalpel, Ultrasonic, Reprocessed

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510(K) Number K143562
Device Name Scalpel, Ultrasonic, Reprocessed
Applicant STERILMED, INC.
11400 73RD AVE. N
Maple Grove, MN 55369 US
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Contact Nicole Boser
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Regulation Number 000.0000

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Classification Product Code NLQ
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Date Received 12/16/2014
Decision Date 05/20/2015
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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