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FDA 510(k) Application Details - K190174
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
510(K) Number
K190174
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
Other 510(k) Applications for this Contact
Regulation Number
882.5550
More FDA Info for this Regulation Number
Classification Product Code
JXG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2019
Decision Date
07/05/2019
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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