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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Columns, Immunoadsorption In Extracorporeal Systems
510(k) Number K831423
Device Name THERAPEUTIC EXCHANGE SYSTEM
Applicant
Extracorporeal Medical Specialities, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Extracorporeal Medical Specialities, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LQQ  
Date Received05/03/1983
Decision Date 01/03/1984
Decision Substantially Equivalent (SESE)
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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