FDA 510(k) Application Details - K970225

Device Classification Name Microfilter, Blood Transfusion

  More FDA Info for this Device
510(K) Number K970225
Device Name Microfilter, Blood Transfusion
Applicant ALPHA THERAPEUTIC CORP.
5555 VALLEY BLVD.
LOS ANGELES, CA 90032 US
Other 510(k) Applications for this Company
Contact M. SUE PRESTON
Other 510(k) Applications for this Contact
Regulation Number 880.5440

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

  More FDA Info for this Product Code
Date Received 01/17/1997
Decision Date 02/14/1997
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