The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco 600 Steam Sterilizer.
Device ID | K183410 |
510k Number | K183410 |
Device Name: | AMSCO 600 Steam Sterilizer |
Classification | Sterilizer, Steam |
Applicant | STERIS Corporation 5960 Heisley Rd. Mentor, OH 44060 |
Contact | Anthony Piotrkowski |
Correspondent | Anthony Piotrkowski STERIS Corporation 5960 Heisley Rd. Mentor, OH 44060 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-10 |
Decision Date | 2019-03-27 |