FDA 510(k) Application Details - K070894

Device Classification Name	Surgical Film   More FDA Info for this Device
510(K) Number	K070894
Device Name	Surgical Film
Applicant	TEPHA, INC. 840 MEMORIAL DRIVE 3RD FLOOR CAMBRIDGE, MA 02139 US Other 510(k) Applications for this Company
Contact	MARY P LEGRAW Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	OOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2007
Decision Date	04/13/2007
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