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510(k) K950518

MIELE G 7781 DENTAL THERMAL DISINFECTOR by Miele Professional — Product Code LDS

K950518 is an FDA 510(k) premarket notification submitted by Miele Professional for the device "MIELE G 7781 DENTAL THERMAL DISINFECTOR". The FDA issued a decision of Substantially Equivalent on January 26, 1996. 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
January 26, 1996
Date Received
February 6, 1995
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

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  • 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)
  • 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