SoftFix Balloon Trocar

Laparoscope, General & Plastic Surgery

Unimax Medical Systems Inc.

The following data is part of a premarket notification filed by Unimax Medical Systems Inc. with the FDA for Softfix Balloon Trocar.

Pre-market Notification Details

Device IDK211577
510k NumberK211577
Device Name:SoftFix Balloon Trocar
ClassificationLaparoscope, General & Plastic Surgery
Applicant Unimax Medical Systems Inc. 8F-2, No. 127, Lane 235, Pao Chiao Road New Taipei,  TW 23145a
ContactMonoj Mon Kalita
CorrespondentMonoj Mon Kalita
Unimax Medical Systems Inc. 8F-2, No. 127, Lane 235, Pao Chiao Road New Taipei,  TW 23145a
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-21
Decision Date2021-11-05

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