510(k) K983068

RELIANCE FAMILY OF WASHER-DISINFECTORS by STERIS Corporation — Product Code LDS

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