FDA 510(k) Application Details - K955525

Device Classification Name Catheter, Continuous Flush

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510(K) Number K955525
Device Name Catheter, Continuous Flush
Applicant INTERVENTIONAL INNOVATIONS CORP.
2670 PATTON RD.
ST. PAUL, MN 55113 US
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Contact THERESA E BRADNER
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 12/04/1995
Decision Date 08/08/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K955525


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