FDA 510(k) Application Details - K051084

Device Classification Name Apparatus, Suction, Patient Care

  More FDA Info for this Device
510(K) Number K051084
Device Name Apparatus, Suction, Patient Care
Applicant DENVER BIOMEDICALS, INC.
433 PARK POINT DRIVE, SUITE 14
GOLDEN, CO 80401 US
Other 510(k) Applications for this Company
Contact NANCY SAUER
Other 510(k) Applications for this Contact
Regulation Number 870.5050

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

  More FDA Info for this Product Code
Date Received 04/28/2005
Decision Date 06/13/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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