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510(k) K183444

Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector by Cenorin, LLC — Product Code LDS

K183444 is an FDA 510(k) premarket notification submitted by Cenorin, LLC for the device "Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector". The FDA issued a decision of Substantially Equivalent on September 9, 2019. The device falls under product code LDS (Device, Pasteurization, Hot Water), a Class II device regulated under 21 CFR 880.6991.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2019
Date Received
December 12, 2018
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

Other clearances for product code LDS

  • K031799 — MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 (November 12, 2003)
  • K983068 — RELIANCE FAMILY OF WASHER-DISINFECTORS (May 31, 2000)
  • K972193 — OLYMPIX MINI-PASTEURMATIC (58210) (September 5, 1997)
  • K950518 — MIELE G 7781 DENTAL THERMAL DISINFECTOR (January 26, 1996)
  • K950566 — DECOMAT 4656 (October 19, 1995)
  • K953645 — OLYMPIC PASTEURMATIC SYSTEM (September 22, 1995)
  • K884151 — MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. (May 16, 1989)
  • K860263 — CASTLE 7538 FLOOR LOADING WASHER (March 5, 1986)
  • K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER (January 14, 1985)
  • K810311 — STERI-VERS (April 17, 1981)

FDA data resources