FDA 510(k) Application Details - K211823

Device Classification Name Device, Acupressure

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510(K) Number K211823
Device Name Device, Acupressure
Applicant WellSpring Pharmaceutical Corporation
5911 North Honore Avenue, Suite 211
Sarasota, FL 34243 US
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Contact Renee Davis Grandchamp
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Regulation Number 000.0000

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Classification Product Code MVV
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Date Received 06/14/2021
Decision Date 09/01/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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