FDA 510(k) Application Details - K003648

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K003648
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	ETZEM TECHNOLOGIES, INC. 20 HATA'AS ST. BEIT HAPA'AMON BOX 124 KFAR SABA 44425 IL Other 510(k) Applications for this Company
Contact	AHAVA SHEIN Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2000
Decision Date	02/23/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review