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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 K971015
Device Name AHCS HEMOPERFUSION SYSTEM
Applicant
American Health Care Systems, Inc.
3350 Ridgelake Ave., Suite 255
Metairie,  LA  70002
Applicant Contact EARL G SCHMIT
Correspondent
American Health Care Systems, Inc.
3350 Ridgelake Ave., Suite 255
Metairie,  LA  70002
Correspondent Contact EARL G SCHMIT
Regulation Number876.5870
Classification Product Code
FLD  
Date Received03/20/1997
Decision Date 10/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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