FDA 510(k) Application Details - K090074

Device Classification Name Sleeve, Limb, Compressible

  More FDA Info for this Device
510(K) Number K090074
Device Name Sleeve, Limb, Compressible
Applicant HYGIA HEALTH SERVICES, INC.
434 INDUSTRIAL LN.
BIRMINGHAM, AL 35211 US
Other 510(k) Applications for this Company
Contact JEROME JAMES
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 01/12/2009
Decision Date 04/22/2009
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