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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K851573
Device Name ABBOTT PHARAMACOKINETICS SYSTEMS
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact MARY E ZORC
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact MARY E ZORC
Regulation Number868.1890
Classification Product Code
NDC  
Date Received04/17/1985
Decision Date 01/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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