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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name station, dialysis control, negative pressure type
510(k) Number K760725
Device Name COIL MACHINE ADAPTER
Original Applicant
GAMBRO, INC.
Regulation Number876.5820
Classification Product Code
FLC  
Date Received09/27/1976
Decision Date 10/27/1976
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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