FDA 510(k) Application Details - K974042

Device Classification Name	Kit, Enema, (For Cleaning Purpose)   More FDA Info for this Device
510(K) Number	K974042
Device Name	Kit, Enema, (For Cleaning Purpose)
Applicant	AMSINO INTL., INC. 833 TOWNE CENTER DR. POMONA, CA 91767 US Other 510(k) Applications for this Company
Contact	RICHARD Y LI Other 510(k) Applications for this Contact
Regulation Number	876.5210   More FDA Info for this Regulation Number
Classification Product Code	FCE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/1997
Decision Date	12/19/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review