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FDA 510(k) Application Details - K070876
Device Classification Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
More FDA Info for this Device
510(K) Number
K070876
Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant
STRYKER CRANIOMAXILLOFACIAL
750 TRADE CENTRE WAY
SUITE 200
KALAMAZOO, MI 49002 US
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Contact
TENNILLE FOLK
Other 510(k) Applications for this Contact
Regulation Number
882.4310
More FDA Info for this Regulation Number
Classification Product Code
HBE
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More FDA Info for this Product Code
Date Received
03/29/2007
Decision Date
04/27/2007
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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