FDA 510(k) Application Details - K000608

Device Classification Name	Staple, Implantable   More FDA Info for this Device
510(K) Number	K000608
Device Name	Staple, Implantable
Applicant	STD MFG., INC. 1063 TURNPIKE ST. P.O. BOX 420 STOUGHTON, MA 02072 US Other 510(k) Applications for this Company
Contact	JIM LOUSARARIAN Other 510(k) Applications for this Contact
Regulation Number	878.4750   More FDA Info for this Regulation Number
Classification Product Code	GDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2000
Decision Date	03/07/2000
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