FDA 510(k) Application Details - K141609

Device Classification Name Sleeve, Limb, Compressible

  More FDA Info for this Device
510(K) Number K141609
Device Name Sleeve, Limb, Compressible
Applicant ALBAHEALTH LLC
425 N GATEWAY AVE.
ROCKWOOD, TN 37854 US
Other 510(k) Applications for this Company
Contact SHANE BRUCE
Other 510(k) Applications for this Contact
Regulation Number 870.5800

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

  More FDA Info for this Product Code
Date Received 06/16/2014
Decision Date 07/15/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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