FDA 510(k) Application Details - K992104

Device Classification Name Set, Administration, Intravascular

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510(K) Number K992104
Device Name Set, Administration, Intravascular
Applicant RD MEDICAL MFG., INC.
CALLE ESCUDERO FINAL, BO.
FULLADOSA
CUELBRA, PR US
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Contact CARLOS A RODRIGUEZ-GARCIA
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 06/22/1999
Decision Date 08/23/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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