The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco V-pro Max Low Temperature Sterilization System.
| Device ID | K102330 |
| 510k Number | K102330 |
| Device Name: | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM |
| Classification | Sterilizer, Chemical |
| 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 | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-17 |
| Decision Date | 2011-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995151997 | K102330 | 000 |
| 00724995206994 | K102330 | 000 |
| 00724995206987 | K102330 | 000 |
| 00724995000028 | K102330 | 000 |