FDA 510(k) Application Details - K092829

Device Classification Name	Applicator For Rectal Suppository   More FDA Info for this Device
510(K) Number	K092829
Device Name	Applicator For Rectal Suppository
Applicant	CHRISTCOT MEDICAL COMPANY PO BOX 104 SUDBURY, MA 01776 US Other 510(k) Applications for this Company
Contact	JENNIFER D ENSIGN Other 510(k) Applications for this Contact
Regulation Number	876.4730   More FDA Info for this Regulation Number
Classification Product Code	OOW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2009
Decision Date	12/02/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review