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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 K884016
Device Name DC-1 I.V. DOSAGE COMPUTER
Applicant
PHASE MEDICAL, INC.
3500 WEST MOORE AVE., SUITE M
SANTA ANA,  CA  92704
Applicant Contact ALAN DAVIDNER
Correspondent
PHASE MEDICAL, INC.
3500 WEST MOORE AVE., SUITE M
SANTA ANA,  CA  92704
Correspondent Contact ALAN DAVIDNER
Regulation Number868.1890
Classification Product Code
NDC  
Date Received09/22/1988
Decision Date 12/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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