SIGMA Sterilization Pouch And Roll

Wrap, Sterilization

Sigma Medical Supplies Corporation

The following data is part of a premarket notification filed by Sigma Medical Supplies Corporation with the FDA for Sigma Sterilization Pouch And Roll.

Pre-market Notification Details

Device IDK202462
510k NumberK202462
Device Name:SIGMA Sterilization Pouch And Roll
ClassificationWrap, Sterilization
Applicant Sigma Medical Supplies Corporation NO.34, Ding-Ping Road, Rui Fang Industrial Park, Rui Fang Dist. New Taipei City,  TW 224
ContactEthan Lin
CorrespondentUta Shih
Sen Mu Technology Co., LTD. I5F-2, No.I, Lane 26, Mincyuan 1st Rd., Lingya District, Kaohsiung City,  TW 802
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-27
Decision Date2021-04-23

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