FDA 510(k) Application Details - K955010

Device Classification Name Apparatus, Autotransfusion

  More FDA Info for this Device
510(K) Number K955010
Device Name Apparatus, Autotransfusion
Applicant BOEHRINGER LABORATORIES
500 E. WASHINGTON ST.
NORRISTOWN, PA 19401 US
Other 510(k) Applications for this Company
Contact JOHN KARPOWICZ
Other 510(k) Applications for this Contact
Regulation Number 868.5830

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

  More FDA Info for this Product Code
Date Received 11/01/1995
Decision Date 06/20/1996
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