Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K132065
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K132065
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
ENDOCHOICE, INC.
11810 WILLS ROAD
ALPHARETTA, GA 30009 US
Other 510(k) Applications for this Company
Contact
THERON GOBER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/03/2013
Decision Date
01/17/2014
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact