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 |