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FDA 510(k) Application Details - K213208
Device Classification Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
More FDA Info for this Device
510(K) Number
K213208
Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant
Biomet Microfixation
1520 Tradeport Drive
Jacksonville, FL 32218 US
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Contact
Mark Wladkowski
Other 510(k) Applications for this Contact
Regulation Number
882.4310
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Classification Product Code
HBE
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More FDA Info for this Product Code
Date Received
09/29/2021
Decision Date
12/23/2021
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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