The following data is part of a premarket notification filed by Steris Corp. with the FDA for Amsco V-pro.
Device ID | K112813 |
510k Number | K112813 |
Device Name: | AMSCO V-PRO |
Classification | Sterilizer, Chemical |
Applicant | STERIS CORP. 5960 HEISLEY RD. Mentor, OH 44060 |
Contact | Robert Sullivan |
Correspondent | Robert Sullivan STERIS CORP. 5960 HEISLEY RD. Mentor, OH 44060 |
Product Code | MLR |
CFR Regulation Number | 880.6860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-27 |
Decision Date | 2011-12-01 |
Summary: | summary |