Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K091417
Device Classification Name
Endoscopic Guidewire, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K091417
Device Name
Endoscopic Guidewire, Gastroenterology-Urology
Applicant
TERUMO CORP.
950 Elkton Blvd.
Elkton, MD 21921 US
Other 510(k) Applications for this Company
Contact
MARK UNTERREINER
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
OCY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/13/2009
Decision Date
05/22/2009
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
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact