Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K172227
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K172227
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
Carbon Medical Technologies, Inc.
1290 Hammond Road
Saint Paul, MN 55110-5867 US
Other 510(k) Applications for this Company
Contact
Andrew J. Adams
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
07/25/2017
Decision Date
08/23/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact