FDA 510(k) Application Details - K131191

Device Classification Name Arthroscope

  More FDA Info for this Device
510(K) Number K131191
Device Name Arthroscope
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
Other 510(k) Applications for this Company
Contact SUSAN KAGAN
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 04/26/2013
Decision Date 07/22/2013
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