Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K042110
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K042110
Device Name
Catheter, Retention Type, Balloon
Applicant
BEAMPOINT AB
6740 RIVERVIEW TERRACE
MINNEAPOLIS, MN 55432 US
Other 510(k) Applications for this Company
Contact
CONSTANCE BUNDY
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/05/2004
Decision Date
02/25/2005
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