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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, perfusion, kidney, disposable
510(k) Number K780470
Device Name H.P. MEDICAL GRADE SILICONE TUBING
Applicant
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5880
Classification Product Code
KDL  
Date Received03/22/1978
Decision Date 04/27/1978
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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