Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K142767
Device Classification Name
Catheter, Urethral
More FDA Info for this Device
510(K) Number
K142767
Device Name
Catheter, Urethral
Applicant
ThinkMed Medical Technology Co., Ltd.
No.4 Building, 322 Hongyang Road, Qiandeng Town
Kunshan 215341 CN
Other 510(k) Applications for this Company
Contact
Garfield Wang
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
GBM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/2014
Decision Date
02/03/2015
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact