Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K030712
Device Classification Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
More FDA Info for this Device
510(K) Number
K030712
Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant
AMSINO INTERNATIONAL, INC.
4501 BRICKELL PRIVADO ST.
ONTARIO, CA 91761 US
Other 510(k) Applications for this Company
Contact
CHING CHING SEAH
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
FCM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/06/2003
Decision Date
05/23/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact