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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 K810315
Device Name ALTERNATE STERILIZ. FOR CELLULOSE ACET
Applicant
CORDIS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CORDIS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received02/05/1981
Decision Date 03/20/1981
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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