FDA 510(k) Application Details - K061345

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K061345
Device Name	Arthroscope
Applicant	ENDIUS, INC. 23 WEST BACON ST. PLAINVILLE, MA 02762 US Other 510(k) Applications for this Company
Contact	CHRISTINE KUNTZ-NASSIF 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	05/15/2006
Decision Date	06/06/2006
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