FDA 510(k) Application Details - K080560

Device Classification Name Arthroscope

  More FDA Info for this Device
510(K) Number K080560
Device Name Arthroscope
Applicant HENKE SASS WOLF OF AMERICA, INC.
106 EAST 5TH AVENUE
MOUNT DORA, FL 32757 US
Other 510(k) Applications for this Company
Contact LYNETTE HOWARD
Other 510(k) Applications for this Contact
Regulation Number 888.1100

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

  More FDA Info for this Product Code
Date Received 02/28/2008
Decision Date 03/18/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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