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510(k) K884151

MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. by Miele Appliances, Inc. — Product Code LDS

K884151 is an FDA 510(k) premarket notification submitted by Miele Appliances, Inc. for the device "MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.". The FDA issued a decision of Substantially Equivalent on May 16, 1989. 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
May 16, 1989
Date Received
October 3, 1988
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)
  • K950518 — MIELE G 7781 DENTAL THERMAL DISINFECTOR (January 26, 1996)
  • K950566 — DECOMAT 4656 (October 19, 1995)
  • K953645 — OLYMPIC PASTEURMATIC SYSTEM (September 22, 1995)
  • 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