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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K000017
Device Name PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400
Applicant
RD MEDICAL MFG., INC.
BO. FULLADOSA
CULEBRA,  PR  00775
Applicant Contact CARLOS A RODRIQUEZ
Correspondent
RD MEDICAL MFG., INC.
BO. FULLADOSA
CULEBRA,  PR  00775
Correspondent Contact CARLOS A RODRIQUEZ
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/03/2000
Decision Date 02/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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