FDA 510(k) Application Details - K200950

Device Classification Name Shunt, Central Nervous System And Components

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510(K) Number K200950
Device Name Shunt, Central Nervous System And Components
Applicant Aesculap, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact Kathy A. Racosky
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Regulation Number 882.5550

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Classification Product Code JXG
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Date Received 04/09/2020
Decision Date 05/08/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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