FDA 510(k) Application Details - K973916

Device Classification Name Set, Administration, Intravascular

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510(K) Number K973916
Device Name Set, Administration, Intravascular
Applicant N.P. MEDICAL, INC.
101 UNION ST.
CLINTON, MA 01510 US
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Contact PAUL A CARACCIOLO
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 10/14/1997
Decision Date 03/09/1998
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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