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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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More FDA Info for this Product Code
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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