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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K761078
Device Name HEMO-CATH I, KIDNEY DIALYSIS CATHETER
Applicant
Medical Disposables Intl., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medical Disposables Intl., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
KOC  
Date Received11/19/1976
Decision Date 12/06/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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