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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name external upper limb tremor stimulator
510(k) Number K182706
Device Name External upper limb tremor stimulator
Applicant
Cala Health, Inc.
875 Mahler Road, Suite 168
Burlingame,  CA  94010
Applicant Contact Scott A. Wilson
Correspondent
Cala Health, Inc.
875 Mahler Road, Suite 168
Burlingame,  CA  94010
Correspondent Contact Scott A. Wilson
Regulation Number882.5897
Classification Product Code
QBC  
Date Received09/27/2018
Decision Date 10/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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