The following data is part of a premarket notification filed by Sigma Medical Supplies Corporation with the FDA for Sigma Sterilization Pouch And Roll.
|Device Name:||SIGMA Sterilization Pouch And Roll|
|Applicant||Sigma Medical Supplies Corporation NO.34, Ding-Ping Road, Rui Fang Industrial Park, Rui Fang Dist. New Taipei City, TW 224|
Sen Mu Technology Co., LTD. I5F-2, No.I, Lane 26, Mincyuan 1st Rd., Lingya District, Kaohsiung City, TW 802
|CFR Regulation Number||880.6850 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|