FDA 510(k) Application Details - K050515

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K050515
Device Name	Screw, Fixation, Intraosseous
Applicant	STRAUMANN USA, INC. 1601 TRAPELO RD. WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	LINDA JALBERT Other 510(k) Applications for this Contact
Regulation Number	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2005
Decision Date	04/05/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review