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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, for peritoneal dialysis, disposable
510(k) Number K812772
Device Name PERITONEAL DIALYSIS CYCLER SET (8UNIT)
Applicant
DRAVON MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DRAVON MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received10/05/1981
Decision Date 10/19/1981
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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