Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K011537
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K011537
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
DYNAMIC TECHNOLOGY CORP.
SCIENCE-BASED INDUSTRIAL PARK
HSINCHU 300 TW
Other 510(k) Applications for this Company
Contact
YAW C YANG
Other 510(k) Applications for this Contact
Regulation Number
876.5860
More FDA Info for this Regulation Number
Classification Product Code
KDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/18/2001
Decision Date
01/07/2002
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