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FDA 510(k) Application Details - K080052
Device Classification Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
More FDA Info for this Device
510(K) Number
K080052
Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Applicant
STRYKER CORP.
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact
VALERIE FRANCK
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
01/08/2008
Decision Date
10/02/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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