FDA 510(k) Application Details - K220485

Device Classification Name Motor, Drill, Electric

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510(K) Number K220485
Device Name Motor, Drill, Electric
Applicant The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens, FL 33410 US
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Contact Marie Ferrier
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Regulation Number 882.4360

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Classification Product Code HBC
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Date Received 02/17/2022
Decision Date 05/19/2022
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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