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FDA 510(k) Application Details - K140938
Device Classification Name
Collector, Ostomy
More FDA Info for this Device
510(K) Number
K140938
Device Name
Collector, Ostomy
Applicant
11 HEALTH AND TECHNOLOGIES LLC
1468 Harwell Avenue
Crofton, MD 21114 US
Other 510(k) Applications for this Company
Contact
E J SMITH
Other 510(k) Applications for this Contact
Regulation Number
876.5900
More FDA Info for this Regulation Number
Classification Product Code
EXB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/11/2014
Decision Date
10/10/2014
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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