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FDA 510(k) Application Details - K030172
Device Classification Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
More FDA Info for this Device
510(K) Number
K030172
Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant
BRASSELER USA I, L.P.
4837 MCGRATH ST., SUITE J
VENTURA, CA 93003 US
Other 510(k) Applications for this Company
Contact
ANTHONY V ROSE
Other 510(k) Applications for this Contact
Regulation Number
882.4310
More FDA Info for this Regulation Number
Classification Product Code
HBE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/17/2003
Decision Date
04/03/2003
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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