FDA 510(k) Application Details - K070836

Device Classification Name	Device, Percutaneous, Biopsy   More FDA Info for this Device
510(K) Number	K070836
Device Name	Device, Percutaneous, Biopsy
Applicant	CLEVEX INC. 9996 CARROUSEL CT LOVELAND, OH 45140 US Other 510(k) Applications for this Company
Contact	LENA SATTLER Other 510(k) Applications for this Contact
Regulation Number	878.4800   More FDA Info for this Regulation Number
Classification Product Code	MJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2007
Decision Date	04/20/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review