FDA 510(k) Application Details - K993695

Device Classification Name	Suture, Absorbable, Natural   More FDA Info for this Device
510(K) Number	K993695
Device Name	Suture, Absorbable, Natural
Applicant	HYSTERX, INC. 18732 SAGINAW IRVINE, CA 92612 US Other 510(k) Applications for this Company
Contact	JUDY F GORDON Other 510(k) Applications for this Contact
Regulation Number	878.4830   More FDA Info for this Regulation Number
Classification Product Code	GAL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/1999
Decision Date	04/13/2000
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