The following data is part of a premarket notification filed by Sigma Medical Supplies Corp. with the FDA for Sigma Sterilization Pouch And Roll.
| Device ID | K180661 |
| 510k Number | K180661 |
| Device Name: | SIGMA Sterilization Pouch And Roll |
| Classification | Wrap, Sterilization |
| Applicant | Sigma Medical Supplies Corp. 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 | 2018-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D89260705600471 | K180661 | 000 |
| D89260705600461 | K180661 | 000 |
| D89260705600451 | K180661 | 000 |