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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 Drive
Palm Beach Gardens,  FL  33410
Applicant Contact Marie Ferrier
Correspondent
Synthes GmbH
Eimattstrasse 3
Oberdorf,  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
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