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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, dialysate delivery, central multiple patient
510(k) Number K781176
Device Name PATIENT AID, MODEL DM-351
Applicant
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
Correspondent
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received07/12/1978
Decision Date 09/07/1978
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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