FDA 510(k) Application Details - K040936

Device Classification Name Bandage, Elastic

  More FDA Info for this Device
510(K) Number K040936
Device Name Bandage, Elastic
Applicant LEDA CO., LTD.
1301 K STREET, NW
SUITE 1100, EAST TOWER
WASHINGTON, DC 20005-3373 US
Other 510(k) Applications for this Company
Contact DAVID J BLOCH
Other 510(k) Applications for this Contact
Regulation Number 880.5075

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

  More FDA Info for this Product Code
Date Received 04/09/2004
Decision Date 05/03/2004
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