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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Hemoperfusion, Sorbent
510(k) Number K840532
Device Name HEMOPERFUSION SYSTEM TP-400
Applicant
Extracorporeal Medical Specialities, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Extracorporeal Medical Specialities, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5870
Classification Product Code
FLD  
Date Received02/01/1984
Decision Date 05/30/1984
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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