The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco V-pro 1 Low Temperature Sterilization System.
| Device ID | K083097 |
| 510k Number | K083097 |
| Device Name: | AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM |
| Classification | Sterilizer, Chemical |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | John R Scoville |
| Correspondent | John R Scoville 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 | 2008-10-17 |
| Decision Date | 2009-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995151980 | K083097 | 000 |