Bonine Acupressure Bands

Device, Acupressure

WellSpring Pharmaceutical Corporation

The following data is part of a premarket notification filed by Wellspring Pharmaceutical Corporation with the FDA for Bonine Acupressure Bands.

Pre-market Notification Details

Device IDK211823
510k NumberK211823
Device Name:Bonine Acupressure Bands
ClassificationDevice, Acupressure
Applicant WellSpring Pharmaceutical Corporation 5911 North Honore Avenue, Suite 211 Sarasota,  FL  34243
ContactRenee Davis Grandchamp
CorrespondentMikel Alberdi
Drug Device Consulting 13014 N. Dale Mabry Hwy., #326 Tampa,  FL  33618
Product CodeMVV  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-14
Decision Date2021-09-01

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