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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 K001102
Device Name PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
Applicant
RD MEDICAL MFG., INC.
BO. FULLADOSA
CULEBRA,  PR  00775
Applicant Contact CARLOS A RODRIGUEZ-GARCIA
Correspondent
RD MEDICAL MFG., INC.
BO. FULLADOSA
CULEBRA,  PR  00775
Correspondent Contact CARLOS A RODRIGUEZ-GARCIA
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/05/2000
Decision Date 04/20/2000
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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