FDA 510(k) Application Details - K023769

Device Classification Name Set, Administration, Intravascular

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510(K) Number K023769
Device Name Set, Administration, Intravascular
Applicant APPRO HEALTHCARE, INC.
847 MAIN ST.
BUFFALO, NY 14203 US
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Contact JOHN R SEMLER
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 11/12/2002
Decision Date 12/30/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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