FDA 510(k) Application Details - K021125

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K021125
Device Name	Condom
Applicant	AAC CONSULTING GROUP, INC. 7361 CALHOUN PL.#500 ROCKVILLE, MD 20855-2774 US Other 510(k) Applications for this Company
Contact	EDUARDO MARCH 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	04/08/2002
Decision Date	10/25/2002
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