FDA 510(k) Application Details - K033762

Device Classification Name	Suture, Absorbable, Synthetic, Polyglycolic Acid   More FDA Info for this Device
510(K) Number	K033762
Device Name	Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant	SERRAL, S.A. DE C.V. 5251-18 JOHN TYLER HWY, SUITE 167 WILLIAMSBURG, VA 23185 US Other 510(k) Applications for this Company
Contact	SCOTT HENDERSON Other 510(k) Applications for this Contact
Regulation Number	878.4493   More FDA Info for this Regulation Number
Classification Product Code	GAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2003
Decision Date	03/15/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review