FDA 510(k) Application Details - K134047

Device Classification Name	Forceps, Surgical, Gynecological   More FDA Info for this Device
510(K) Number	K134047
Device Name	Forceps, Surgical, Gynecological
Applicant	INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE YORK, PA 17402 US Other 510(k) Applications for this Company
Contact	RUTHANNE VENDY Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HCZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2013
Decision Date	04/11/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review