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FDA 510(k) Application Details - K073336
Device Classification Name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
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510(K) Number
K073336
Device Name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Applicant
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact
EMILY E VALERIO
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Regulation Number
882.4305
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Classification Product Code
HBF
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More FDA Info for this Product Code
Date Received
11/28/2007
Decision Date
01/04/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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