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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 K011571
FOIA Releasable 510(k) K011571
Device Name TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
Applicant
The RX Files Corp.
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
The RX Files Corp.
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number868.1890
Classification Product Code
NDC  
Date Received05/21/2001
Decision Date 08/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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