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FDA 510(k) Application Details - K021327
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K021327
Device Name
Neurological Stereotaxic Instrument
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact
GEORGE KELLER
Other 510(k) Applications for this Contact
Regulation Number
882.4560
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Classification Product Code
HAW
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More FDA Info for this Product Code
Date Received
04/26/2002
Decision Date
07/25/2002
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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