FDA 510(k) Application Details - K000736

Device Classification Name	Douche Apparatus, Vaginal, Therapeutic   More FDA Info for this Device
510(K) Number	K000736
Device Name	Douche Apparatus, Vaginal, Therapeutic
Applicant	GOOMI EHWA, INC. P.O. BOX 2123 CUPERTINO, CA 95015 US Other 510(k) Applications for this Company
Contact	MANOH PARK Other 510(k) Applications for this Contact
Regulation Number	884.5900   More FDA Info for this Regulation Number
Classification Product Code	HED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2000
Decision Date	08/08/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review