FDA 510(k) Application Details - K955721

Device Classification Name Airway, Oropharyngeal, Anesthesiology

  More FDA Info for this Device
510(K) Number K955721
Device Name Airway, Oropharyngeal, Anesthesiology
Applicant MALLINCKRODT MEDICAL
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS, MO 63134 US
Other 510(k) Applications for this Company
Contact ROBERT A BIRAG
Other 510(k) Applications for this Contact
Regulation Number 868.5110

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

  More FDA Info for this Product Code
Date Received 12/18/1995
Decision Date 03/28/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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