The following data is part of a premarket notification filed by Steris Corporation with the FDA for Vhp 136 Low Temperature Sterilization System.
| Device ID | K062297 |
| 510k Number | K062297 |
| Device Name: | VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM |
| Classification | Sterilizer, Chemical |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Patrick J Mccullagh |
| Correspondent | Patrick J Mccullagh STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-07 |
| Decision Date | 2007-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995151973 | K062297 | 000 |
| 10724995089518 | K062297 | 000 |
| 10724995089167 | K062297 | 000 |