FDA 510(k) Application Details - K003898

Device Classification Name Arthroscope

  More FDA Info for this Device
510(K) Number K003898
Device Name Arthroscope
Applicant EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY, NJ 07054 US
Other 510(k) Applications for this Company
Contact JON CAPAROTTA
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 12/18/2000
Decision Date 01/04/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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