The following data is part of a premarket notification filed by Sigma Medical Supplies Corporation with the FDA for Sterilization Pouch/roll Made With Tyvek.
Device ID | K180672 |
510k Number | K180672 |
Device Name: | Sterilization Pouch/Roll Made With Tyvek |
Classification | Wrap, Sterilization |
Applicant | Sigma Medical Supplies Corporation NO.34, Ding-Ping Road, Rui Fang Industrial Park, Rui Fang Dist. New Taipei City, TW 224 |
Contact | Mason Huang |
Correspondent | Uta Shih Sen Mu Technology Co., LTD. 15F.-2, No.1, Lane 26, Mincyuan 1st Rd., Lingya District Kaohsiung City, TW 802 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-14 |
Decision Date | 2018-06-06 |
Summary: | summary |