FDA 510(k) Application Details - K964634

Device Classification Name	Dilator, Rectal   More FDA Info for this Device
510(K) Number	K964634
Device Name	Dilator, Rectal
Applicant	MK CONQUEST INTL., INC. 100 EAST 15TH ST. SUITE 320 FORT WORTH, TX 76102 US Other 510(k) Applications for this Company
Contact	RICHARD A HAMER Other 510(k) Applications for this Contact
Regulation Number	876.5450   More FDA Info for this Regulation Number
Classification Product Code	FFP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/1996
Decision Date	06/06/1997
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