FDA 510(k) Application Details - K051053

Device Classification Name	Instrument, Surgical, Sonic And Accessory/Attachment   More FDA Info for this Device
510(K) Number	K051053
Device Name	Instrument, Surgical, Sonic And Accessory/Attachment
Applicant	ORTHOSONICS, LTD. 2305 GOLD MINE RD. BROOKEVILLE, MD 20833 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY 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	04/25/2005
Decision Date	07/21/2005
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