FDA 510(k) Application Details - K961155

Device Classification Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

  More FDA Info for this Device
510(K) Number K961155
Device Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant DOUGLAS MEDICAL PRODUCTS CORP.
1840 INDUSTRIAL DR., SUITE 200
LIBERTYVILLE, IL 60048 US
Other 510(k) Applications for this Company
Contact RON HASELHORST
Other 510(k) Applications for this Contact
Regulation Number 880.5970

  More FDA Info for this Regulation Number
Classification Product Code LJS
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/22/1996
Decision Date 06/18/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact