FDA 510(k) Application Details - K960243

Device Classification Name	Labor And Delivery Kit   More FDA Info for this Device
510(K) Number	K960243
Device Name	Labor And Delivery Kit
Applicant	CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 ORLANDO, FL 32811 US Other 510(k) Applications for this Company
Contact	RICHARD L ELLWOOD Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MLS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/1996
Decision Date	05/23/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review