The following data is part of a premarket notification filed by Steris Corporation with the FDA for Ras 12 Rack, Ras 12 Long Rack; Ras Cycle Of Amsco 7052hp/7053hp Single Chamber Washer/disinfector.
Device ID | K190081 |
510k Number | K190081 |
Device Name: | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle Of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector |
Classification | Washer, Cleaner, Automated, Endoscope |
Applicant | STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
Contact | Marcia L Benedict |
Correspondent | Marcia L Benedict STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
Product Code | NVE |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-01-16 |
Decision Date | 2019-08-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00724995176730 | K190081 | 000 |
00724995176723 | K190081 | 000 |