FDA 510(k) Application Details - K032150

Device Classification Name Set, Administration, Intravascular

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510(K) Number K032150
Device Name Set, Administration, Intravascular
Applicant SARSTEDT, INC.
1025 ST. JAMES CHURCH RD.
PO BOX 468
NEWTON, NC 28658 US
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Contact PETER RUMSWINKEL
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 07/14/2003
Decision Date 09/12/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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