FDA 510(k) Application Details - K021247

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K021247
Device Name	Insufflator, Laparoscopic
Applicant	MECTRA LABS, INC. P.O. BOX 350 BLOOMFIELD, IN 47424 US Other 510(k) Applications for this Company
Contact	CHARLES E ALLGOOD Other 510(k) Applications for this Contact
Regulation Number	884.1730   More FDA Info for this Regulation Number
Classification Product Code	HIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2002
Decision Date	11/08/2002
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