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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, acupressure
510(k) Number K211823
Device Name Bonine Acupressure Bands
WellSpring Pharmaceutical Corporation
5911 North Honore Avenue, Suite 211
Sarasota,  FL  34243
Applicant Contact Renee Davis Grandchamp
Drug Device Consulting
13014 N. Dale Mabry Hwy., #326
Tampa,  FL  33618
Correspondent Contact Mikel Alberdi
Classification Product Code
Date Received06/14/2021
Decision Date 09/01/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No