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FDA 510(k) Application Details - K150801
Device Classification Name
Motor, Drill, Pneumatic
More FDA Info for this Device
510(K) Number
K150801
Device Name
Motor, Drill, Pneumatic
Applicant
STRYKER CORPORATION
4100 E. MILHAM AVENUE
KALAMAZOO, MI 49001 US
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Contact
DEVAL PATEL
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Regulation Number
882.4370
More FDA Info for this Regulation Number
Classification Product Code
HBB
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More FDA Info for this Product Code
Date Received
03/26/2015
Decision Date
05/22/2015
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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