FDA 510(k) Application Details - K970443

Device Classification Name	Device, Paste-On For Incontinence, Sterile   More FDA Info for this Device
510(K) Number	K970443
Device Name	Device, Paste-On For Incontinence, Sterile
Applicant	HOLLISTER, INC. 2000 HOLLISTER DR. LIBERTYVILLE, IL 60048 US Other 510(k) Applications for this Company
Contact	JOSEPH S TOKARZ Other 510(k) Applications for this Contact
Regulation Number	876.5250   More FDA Info for this Regulation Number
Classification Product Code	EXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/1997
Decision Date	02/25/1997
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