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FDA 510(k) Application Details - K022287
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K022287
Device Name
Catheter, Retention Type, Balloon
Applicant
3T MEDICAL SYSTEMS, LLC.
12553 S. WAMBLEE VALLEY RD.
CONIFER, CO 80433-6204 US
Other 510(k) Applications for this Company
Contact
ROBERT P EATON
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
EZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/15/2002
Decision Date
09/23/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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