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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 K010538
Device Name PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E
Applicant
Rd Medical Mfg., Inc.
Calle Escudero Final, Bo.
Fulladosa
Cuelbra,  PR  00775
Applicant Contact CARLOS A RODRIGUEZ-GARCIA
Correspondent
Rd Medical Mfg., Inc.
Calle Escudero Final, Bo.
Fulladosa
Cuelbra,  PR  00775
Correspondent Contact CARLOS A RODRIGUEZ-GARCIA
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/23/2001
Decision Date 03/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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