FDA 510(k) Application Details - K970997

Device Classification Name Needle, Spinal, Short Term

  More FDA Info for this Device
510(K) Number K970997
Device Name Needle, Spinal, Short Term
Applicant KLEIN-BAKER MEDICAL, INC.
12001 NETWORK, SUITE 110
SAN ANTONIO, TX 78249 US
Other 510(k) Applications for this Company
Contact CLYDE N BAKER
Other 510(k) Applications for this Contact
Regulation Number 868.5150

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

  More FDA Info for this Product Code
Date Received 03/19/1997
Decision Date 05/22/1997
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