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FDA 510(k) Application Details - K141935
Device Classification Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
More FDA Info for this Device
510(K) Number
K141935
Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO, MI 49001 US
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Contact
VISHAL KANANI
Other 510(k) Applications for this Contact
Regulation Number
874.4250
More FDA Info for this Regulation Number
Classification Product Code
ERL
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More FDA Info for this Product Code
Date Received
07/17/2014
Decision Date
09/26/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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