FDA 510(k) Application Details - K113525

Device Classification Name Sleeve, Limb, Compressible

  More FDA Info for this Device
510(K) Number K113525
Device Name Sleeve, Limb, Compressible
Applicant MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
117 AHUZAH ST.
RA'ANANNA 43373 43373 IL
Other 510(k) Applications for this Company
Contact JONATHAN S KAHAN
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 11/29/2011
Decision Date 01/31/2012
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 N
Expedited Review



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