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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 K801355
Device Name BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
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
KOC  
Date Received06/09/1980
Decision Date 07/08/1980
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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