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FDA 510(k) Application Details - K062413
Device Classification Name
Rongeur, Powered
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510(K) Number
K062413
Device Name
Rongeur, Powered
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
882.4845
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Classification Product Code
HAD
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More FDA Info for this Product Code
Date Received
08/17/2006
Decision Date
11/21/2006
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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