FDA 510(k) Application Details - K080200

Device Classification Name	Douche Apparatus, Vaginal, Therapeutic   More FDA Info for this Device
510(K) Number	K080200
Device Name	Douche Apparatus, Vaginal, Therapeutic
Applicant	ABBOTT RESEARCH GROUP, INC. 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	ROSINA ROBINSON 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	01/25/2008
Decision Date	07/10/2008
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