FDA 510(k) Application Details - K022942

Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)

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510(K) Number K022942
Device Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact GEORG KELLER
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Regulation Number 882.4310

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Classification Product Code HBE
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Date Received 09/05/2002
Decision Date 10/21/2002
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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