FDA 510(k) Application Details - K993781

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K993781
Device Name	Condom
Applicant	P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG. 7 RIVERVIEW RD. FRAMINGHAM, MA 01701 US Other 510(k) Applications for this Company
Contact	VIJAY MAHAL Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	HIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/1999
Decision Date	02/02/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review