FDA 510(k) Application Details - K992902

Device Classification Name Catheters, Suction, Tracheobronchial

  More FDA Info for this Device
510(K) Number K992902
Device Name Catheters, Suction, Tracheobronchial
Applicant AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM, MD 21090-1356 US
Other 510(k) Applications for this Company
Contact SANJAY PARIKH
Other 510(k) Applications for this Contact
Regulation Number 868.6810

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

  More FDA Info for this Product Code
Date Received 08/30/1999
Decision Date 10/25/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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