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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Pasteurization, Hot Water
510(k) Number K884151
Device Name MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.
Applicant
Miele Appliances, Inc.
22d Worlds Fair Dr.
Somerset,  NJ  08873
Applicant Contact DENIS J O'BRIEN
Correspondent
Miele Appliances, Inc.
22d Worlds Fair Dr.
Somerset,  NJ  08873
Correspondent Contact DENIS J O'BRIEN
Regulation Number880.6991
Classification Product Code
LDS  
Date Received10/03/1988
Decision Date 05/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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