The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Tyvek Self-seal Pouches With Sterrad Chemical Indicator, Tyvek Rolls With Sterrad Chemical Indicator, Tyvek Heat-seal Pouches With Sterrad Chemical Indicator.
| Device ID | K163598 |
| 510k Number | K163598 |
| Device Name: | Tyvek Self-Seal Pouches With STERRAD Chemical Indicator, Tyvek Rolls With STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches With STERRAD Chemical Indicator |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR Irvine, CA 92612 |
| Contact | Nazanin Yacobi |
| Correspondent | Nazanin Yacobi ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR Irvine, CA 92612 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-21 |
| Decision Date | 2017-07-31 |
| Summary: | summary |