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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 K832623
Device Name TOP DISPOS. INFUSION SET/HEMODIALY
Applicant
Top Surgical Manufacturers Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Top Surgical Manufacturers Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
KOC  
Date Received08/04/1983
Decision Date 10/14/1983
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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