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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K953805
Device Name 0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
Applicant
ABBOTT LABORATORIES
DEPT. 389, AP30
ABBOTT PARK,  IL  60064 -3537
Applicant Contact THOMAS F WILLER
Correspondent
ABBOTT LABORATORIES
DEPT. 389, AP30
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact THOMAS F WILLER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/08/1995
Decision Date 06/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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