The following data is part of a premarket notification filed by Steris Corporation with the FDA for Vis-u-all Ii Self Seal Pouch.
| Device ID | K070765 |
| 510k Number | K070765 |
| Device Name: | VIS-U-ALL II SELF SEAL POUCH |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Patrick Mccullagh |
| Correspondent | Patrick Mccullagh 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 | 2007-03-20 |
| Decision Date | 2007-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50724995003239 | K070765 | 000 |
| 50724995003116 | K070765 | 000 |
| 50724995003109 | K070765 | 000 |
| 50724995003093 | K070765 | 000 |
| 50724995003086 | K070765 | 000 |
| 50724995003079 | K070765 | 000 |
| 50724995003062 | K070765 | 000 |
| 50724995003055 | K070765 | 000 |
| 50724995003048 | K070765 | 000 |
| 50724995003123 | K070765 | 000 |
| 50724995003130 | K070765 | 000 |
| 50724995003147 | K070765 | 000 |
| 50724995003222 | K070765 | 000 |
| 50724995003215 | K070765 | 000 |
| 50724995003208 | K070765 | 000 |
| 50724995003192 | K070765 | 000 |
| 50724995003185 | K070765 | 000 |
| 50724995003178 | K070765 | 000 |
| 50724995003161 | K070765 | 000 |
| 50724995003154 | K070765 | 000 |
| 50724995003031 | K070765 | 000 |