FDA 510(k) Application Details - K100410

Device Classification Name	Instrument, Surgical, Sonic And Accessory/Attachment   More FDA Info for this Device
510(K) Number	K100410
Device Name	Instrument, Surgical, Sonic And Accessory/Attachment
Applicant	SATELEC 124 GAITHER DRIVE SUITE 140 MT. LAUREL, NJ 08054 US Other 510(k) Applications for this Company
Contact	RICK ROSATI 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	02/16/2010
Decision Date	04/28/2010
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