FDA 510(k) Application Details - K991601

Device Classification Name Catheter, Percutaneous

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510(K) Number K991601
Device Name Catheter, Percutaneous
Applicant ENDOLOGIX, INC.
20 FAIRBANKS, SUITE #173
IRVINE, CA 92618 US
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Contact KAREN U SALINAS
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 05/10/1999
Decision Date 10/28/1999
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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