FDA 510(k) Application Details - K172843

Device Classification Name Stimulator, Nerve, Peripheral, Electric

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510(K) Number K172843
Device Name Stimulator, Nerve, Peripheral, Electric
Applicant Blink Device Corporation
1530 Westlake Ave N Suite 600
Seattle, WA 98109 US
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Contact Justin Hulvershorn
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Regulation Number 868.2775

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Classification Product Code KOI
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Date Received 09/19/2017
Decision Date 03/29/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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