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FDA 510(k) Application Details - K183545
Device Classification Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
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510(K) Number
K183545
Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens, FL 33410 US
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Contact
Tamara J. West
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
12/20/2018
Decision Date
07/19/2019
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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