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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Peripheral, Electric
510(k) Number K192958
Device Name TwitchView System
Applicant
Blink Device Company
1530 Westlake Ave. N Suite 600
Seattle,  WA  98109
Applicant Contact Justin Hulvershorn
Correspondent
Blink Device Company
1530 Westlake Ave. N Suite 600
Seattle,  WA  98109
Correspondent Contact Justin Hulvershorn
Regulation Number868.2775
Classification Product Code
KOI  
Date Received10/22/2019
Decision Date 04/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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