FDA 510(k) Application Details - K083830

Device Classification Name	Instrument, Surgical, Sonic And Accessory/Attachment   More FDA Info for this Device
510(K) Number	K083830
Device Name	Instrument, Surgical, Sonic And Accessory/Attachment
Applicant	ORTHOSONICS, LTD. BREMRIDGE HOUSE ASHBURTON, DEVON TQ137JX GB Other 510(k) Applications for this Company
Contact	MICHAEL J YOUNG Other 510(k) Applications for this Contact
Regulation Number	888.4580   More FDA Info for this Regulation Number
Classification Product Code	JDX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2008
Decision Date	03/20/2009
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