FDA 510(k) Application Details - K081404

Device Classification Name Catheter, Conduction, Anesthetic

  More FDA Info for this Device
510(K) Number K081404
Device Name Catheter, Conduction, Anesthetic
Applicant SPINAL INTEGRATION LLC
6314 KINGSPOINTE PKWY UNIT 6
ORLANDO, FL 32819 US
Other 510(k) Applications for this Company
Contact TRUDIE L SEEGER
Other 510(k) Applications for this Contact
Regulation Number 868.5120

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

  More FDA Info for this Product Code
Date Received 05/19/2008
Decision Date 10/21/2008
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