FDA 510(k) Application Details - K955293

Device Classification Name Device, Vascular, For Promoting Embolization

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510(K) Number K955293
Device Name Device, Vascular, For Promoting Embolization
Applicant TARGET THERAPEUTICS
47201 LAKEVIEW BLVD.
P.O. BOX 5120
FREEMONT, CA 94538 US
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Contact LARAINE PANGELINA
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Regulation Number 870.3300

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Classification Product Code KRD
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Date Received 11/16/1995
Decision Date 02/06/1996
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



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