FDA 510(k) Application Details - K101523

Device Classification Name Sleeve, Limb, Compressible

  More FDA Info for this Device
510(K) Number K101523
Device Name Sleeve, Limb, Compressible
Applicant DEVON MEDICAL INC.
1100 1ST AVENUE
SUITE 100
KING OF PRUSSIA, PA 19406 US
Other 510(k) Applications for this Company
Contact RUTH WU
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 06/02/2010
Decision Date 06/17/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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