FDA 510(k) Application Details - K963307

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K963307
Device Name Device, Neurovascular 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 882.5950

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Classification Product Code HCG
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Date Received 08/22/1996
Decision Date 12/17/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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