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FDA 510(k) Application Details - K181346
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K181346
Device Name
Catheter, Retention Type, Balloon
Applicant
Emmy Medical, LLC.
18 Hillside Drive
Holliston, MA 01746 US
Other 510(k) Applications for this Company
Contact
Ronald Adams
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
05/21/2018
Decision Date
08/06/2018
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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