FDA 510(k) Application Details - K971590

Device Classification Name	Condom, Synthetic   More FDA Info for this Device
510(K) Number	K971590
Device Name	Condom, Synthetic
Applicant	SENSICON CORP. 2595 COMMERCE WAY VISTA, CA 92083 US Other 510(k) Applications for this Company
Contact	JORGE HAIDER Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	MOL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/1997
Decision Date	10/07/1997
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