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FDA 510(k) Applications Submitted by Monoj Mon Kalita
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180115
01/16/2018
TWBM Pump
Taiwan Biomaterial Co., Ltd.
K190105
01/22/2019
ZOOM Aspiration Pump
Taiwan Biomaterial Co., Ltd.
K211577
05/21/2021
SoftFix Balloon Trocar
Unimax Medical Systems Inc.
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