FDA 510(k) Application Details - K953360

Device Classification Name	Laparoscope, Gynecologic (And Accessories)   More FDA Info for this Device
510(K) Number	K953360
Device Name	Laparoscope, Gynecologic (And Accessories)
Applicant	R-MED, INC. 3465 NAVARRE AVE., BOX 167636 OREGON, OH 43616-7636 US Other 510(k) Applications for this Company
Contact	EROL D RIZA Other 510(k) Applications for this Contact
Regulation Number	884.1720   More FDA Info for this Regulation Number
Classification Product Code	HET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/1995
Decision Date	01/11/1996
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