Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K000070
Device Classification Name
Catheter, Urological
More FDA Info for this Device
510(K) Number
K000070
Device Name
Catheter, Urological
Applicant
RUSCH INTL.
TALL PINES PARK
JAFFREY, NH 03452 US
Other 510(k) Applications for this Company
Contact
KARENANN J BROZOWSKI
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
KOD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2000
Decision Date
02/18/2000
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