FDA 510(k) Application Details - K931220

Device Classification Name	Condom With Nonoxynol-9   More FDA Info for this Device
510(K) Number	K931220
Device Name	Condom With Nonoxynol-9
Applicant	MONSYS USA, INC. 116 NORTH MAIN ST. PHILIPPI, WV 26416 US Other 510(k) Applications for this Company
Contact	FRANK FINOCCHIARO Other 510(k) Applications for this Contact
Regulation Number	884.5310   More FDA Info for this Regulation Number
Classification Product Code	LTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/1993
Decision Date	05/22/1996
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