510(k) K983068
K983068 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "RELIANCE FAMILY OF WASHER-DISINFECTORS". The FDA issued a decision of Substantially Equivalent on May 31, 2000. The device falls under product code LDS (Device, Pasteurization, Hot Water), a Class II device regulated under 21 CFR 880.6991. STERIS Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2000
- Date Received
- September 2, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Pasteurization, Hot Water
- Device Class
- Class II
- Regulation Number
- 880.6991
- Review Panel
- HO
- Submission Type