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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 K770552
Device Name CATHETER, KIDNEY DIALYSIS, HEMO-CATH II
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 Received03/21/1977
Decision Date 03/30/1977
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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