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FDA 510(k) Application Details - K992796
Device Classification Name
Catheter, Ventricular
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510(K) Number
K992796
Device Name
Catheter, Ventricular
Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE, FL 32935 US
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Contact
MICHAEL RENNER
Other 510(k) Applications for this Contact
Regulation Number
882.4100
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Classification Product Code
HCA
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More FDA Info for this Product Code
Date Received
08/19/1999
Decision Date
10/25/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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