Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071202
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K071202
Device Name
Catheter, Hemodialysis, Implanted
Applicant
DERMAPORT, INC
800 LEVANGER LANE
STOUGHTON, WI 53589 US
Other 510(k) Applications for this Company
Contact
Gary Syring
Other 510(k) Applications for this Contact
Regulation Number
876.5540
More FDA Info for this Regulation Number
Classification Product Code
MSD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/01/2007
Decision Date
11/30/2007
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact