Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-