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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 K950566
Device Name DECOMAT 4656
Applicant
Getinge Disinfection, Inc.
1415 Hooper Ave.
Box H
Toms River,  NJ  08753
Applicant Contact VINCENT J KOREN
Correspondent
Getinge Disinfection, Inc.
1415 Hooper Ave.
Box H
Toms River,  NJ  08753
Correspondent Contact VINCENT J KOREN
Regulation Number880.6991
Classification Product Code
LDS  
Date Received02/08/1995
Decision Date 10/19/1995
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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