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FDA 510(k) Application Details - K061766
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K061766
Device Name
Catheter, Straight
Applicant
PERCUTANEOUS SYSTEMS, INCORPORATED
1300 CRITTENDEN LANE
SUITE 101
MOUNTAIN VIEW, CA 94043 US
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Contact
THOMAS LAWSON
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
EZD
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More FDA Info for this Product Code
Date Received
06/22/2006
Decision Date
03/09/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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