FDA 510(k) Application Details - K152960

Device Classification Name Motor, Drill, Electric

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510(K) Number K152960
Device Name Motor, Drill, Electric
Applicant AESCULAP, INC.
3773 CORPORATE PARKWAY
CENTER VALLEY, PA 18034 US
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Contact PETER STOLL
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Regulation Number 882.4360

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Classification Product Code HBC
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Date Received 10/07/2015
Decision Date 07/22/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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