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FDA 510(k) Application Details - K150550
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K150550
Device Name
Catheter, Retention Type, Balloon
Applicant
COVALON TECHNOLOGIES, INC.
405 BRITANNIA RD. EAST
SUITE 106
MISSISSAUGA L4Z 3E6 CA
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Contact
Kim Crooks
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2015
Decision Date
11/24/2015
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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