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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Electric
510(k) Number K220485
Device Name Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
Applicant
The Anspach Effort, Inc.
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact Marie Ferrier
Correspondent
Synthes GmbH
Eimattstrasse 3
Oberdor,  CH 4436
Correspondent Contact Marie Ferrier
Regulation Number882.4360
Classification Product Code
HBC  
Subsequent Product Code
ERL  
Date Received02/17/2022
Decision Date 05/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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