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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, peritoneal, automatic delivery
510(k) Number K895336
Device Name ABBOTT INPERSOL CYCLER 1000
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact FREDERICK GUSTAFSON
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact FREDERICK GUSTAFSON
Regulation Number876.5630
Classification Product Code
FKX  
Date Received08/31/1989
Decision Date 11/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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