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FDA 510(k) Application Details - K973083
Device Classification Name
Neurosurgical Paddie
More FDA Info for this Device
510(K) Number
K973083
Device Name
Neurosurgical Paddie
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
183 PROVIDENCE, NEW LONDON
TNPK., P.O. BOX 326
NORTH STONINGTON, CT 06359 US
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Contact
GEORGE P KORTEWEG
Other 510(k) Applications for this Contact
Regulation Number
882.4700
More FDA Info for this Regulation Number
Classification Product Code
HBA
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More FDA Info for this Product Code
Date Received
08/18/1997
Decision Date
12/09/1997
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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