FDA 510(k) Application Details - K071823

Device Classification Name	Facial Implant   More FDA Info for this Device
510(K) Number	K071823
Device Name	Facial Implant
Applicant	SURGISIL 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA J NOLTE Other 510(k) Applications for this Contact
Regulation Number	878.3500   More FDA Info for this Regulation Number
Classification Product Code	ODU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2007
Decision Date	09/19/2007
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