FDA 510(k) Application Details - K960832

Device Classification Name Catheter, Intravascular Occluding, Temporary

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510(K) Number K960832
Device Name Catheter, Intravascular Occluding, Temporary
Applicant INTERVENTIONAL THERAPEUTICS CORP.
48668 MILMONT DR.
FREMONT, CA 94538 US
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Contact LYNN K BELL
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Regulation Number 870.4450

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Classification Product Code MJN
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Date Received 02/29/1996
Decision Date 05/29/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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