FDA 510(k) Application Details - K060198

Device Classification Name Arthroscope

  More FDA Info for this Device
510(K) Number K060198
Device Name Arthroscope
Applicant LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO, FL 33773-4908 US
Other 510(k) Applications for this Company
Contact ELIZABETH PAUL
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 01/26/2006
Decision Date 05/11/2006
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