The following data is part of a premarket notification filed by Sigma Medical Supplies Corp. with the FDA for Sterilization Pouch/roll Made With Tyvek.
| Device ID | K133838 |
| 510k Number | K133838 |
| Device Name: | STERILIZATION POUCH/ROLL MADE WITH TYVEK |
| Classification | Wrap, Sterilization |
| Applicant | SIGMA MEDICAL SUPPLIES CORP. 15F-2, LN 26, MINEYUAN 1ST RD LINGYA DISTRICT Kaohsiung City, TW 802 |
| Contact | Uta Shih |
| Correspondent | Uta Shih SIGMA MEDICAL SUPPLIES CORP. 15F-2, LN 26, MINEYUAN 1ST RD LINGYA DISTRICT Kaohsiung City, TW 802 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-18 |
| Decision Date | 2015-03-11 |
| Summary: | summary |