The following data is part of a premarket notification filed by Steris Corporation with the FDA for Vis-u-all Low Temperature Tyvek Sterilization Pouch For Ethylene Oxide, Models: Self And Heat Seal Pouches, Heat Seal Tu.
| Device ID | K092745 |
| 510k Number | K092745 |
| Device Name: | VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Robert F Sullivan |
| Correspondent | Robert F Sullivan STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-08 |
| Decision Date | 2010-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50724995164084 | K092745 | 000 |
| 50724995164077 | K092745 | 000 |
| 50724995164060 | K092745 | 000 |
| 50724995164053 | K092745 | 000 |
| 50724995164046 | K092745 | 000 |