FDA 510(k) Application Details - K010371

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K010371
Device Name	Condom
Applicant	SURETEX, LTD. 1500 INDUSTRIAL RD. P.O. BOX 1252 DOTHAN, AL 36302 US Other 510(k) Applications for this Company
Contact	LON D MCILVAIN 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	02/07/2001
Decision Date	04/27/2001
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