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 ID | K202462 |
| 510k Number | K202462 |
| Device Name: | SIGMA Sterilization Pouch And Roll |
| 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 | Ethan Lin |
| Correspondent | Uta Shih Sen Mu Technology Co., LTD. I5F-2, No.I, 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 | 2020-08-27 |
| Decision Date | 2021-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D89260705601492 | K202462 | 000 |
| D89260705601482 | K202462 | 000 |
| D89260705601472 | K202462 | 000 |
| 04717048508479 | K202462 | 000 |